510(k) · Cleared
Recalled · Class II · 2012Sarns 8000 Modular Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Jul 8, 1992 after a 233-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 45 times.
- Decided
- Jul 8, 1992
- Review
- 233 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 45
- Predicates
- 0
31 later devices descend from it, 3 citing it directly. 3 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992
- Descendant · cites it directly · 29 of its ownK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- Descendant · cites it directly · 26 of its ownK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK112587 Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump…Terumo Cardiovascular Systems Corp. · 2011
- Descendant · 2 generations on · 8 of its ownK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
1996high 5 (2023) · low 0 (1997)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K953901Sarns 800 Roller Pump3M Health Care, Sarns · 1996 · cites it directly29descendants
- K022947Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Terumo Cardiovascular Systems Corp. · 2003 · cites it directly26descendants
- K112587Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,Terumo Cardiovascular Systems Corp. · 2011 · 2 generations on8descendants
- K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · 2 generations on8descendants
- K131041Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | — |
| +1 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| +1 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| +2 | K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch… | Terumo Cardiovascular Systems Corp. | 2011 | — |
| +2 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| +2 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2013 | 3 | 1 |
| 2014 | 3 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2012 | Class II | Z-0130-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0128-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0129-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0126-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0127-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0131-2013 | Labeling design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports… |
| Sep 25, 2012 | Class II | Z-0281-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Sep 25, 2012 | Class II | Z-0285-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Sep 25, 2012 | Class II | Z-0280-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Sep 25, 2012 | Class II | Z-0282-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Sep 25, 2012 | Class II | Z-0283-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Sep 25, 2012 | Class II | Z-0284-2013 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized… |
| Jun 20, 2012 | Class III | Z-2218-2012 | Labeling mix-ups | During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the… |
| Jun 18, 2012 | Class II | Z-2045-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Jun 18, 2012 | Class II | Z-2046-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Jun 18, 2012 | Class II | Z-2047-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Jun 18, 2012 | Class II | Z-2048-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Jun 18, 2012 | Class II | Z-2044-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Jun 18, 2012 | Class II | Z-2049-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over… |
| Mar 21, 2012 | Not classified | Z-1450-2012 | Device Design | Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by… |
| Mar 21, 2012 | Not classified | Z-1452-2012 | Device Design | Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by… |
| Mar 21, 2012 | Not classified | Z-1453-2012 | Device Design | Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by… |
| Mar 21, 2012 | Not classified | Z-1451-2012 | Device Design | Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by… |
| Oct 21, 2011 | Not classified | Z-0303-2012 | Employee error | Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection… |
| May 3, 2011 | Not classified | Z-2614-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2620-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2613-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2615-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2621-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2618-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2616-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2619-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2617-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| Nov 2, 2010 | Not classified | Z-0562-2011 | Other | The system 8000 roller pumps may fail resulting in a persistent pump stop. |
| Nov 2, 2010 | Not classified | Z-0563-2011 | Other | The system 8000 roller pumps may fail resulting in a persistent pump stop. |
| Aug 12, 2009 | Class II | Z-2348-2012 | Mixed-up of materials/components | Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit… |
| Sep 14, 2006 | Not classified | Z-0238-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Sep 14, 2006 | Not classified | Z-0241-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Sep 14, 2006 | Not classified | Z-0236-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Sep 14, 2006 | Not classified | Z-0237-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Sep 14, 2006 | Not classified | Z-0239-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Sep 14, 2006 | Not classified | Z-0240-2007 | Other | The hand crank handle may separate and detach from the unit during use. |
| Jul 1, 2004 | Not classified | Z-1002-2007 | Other | Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in… |
| Jul 1, 2004 | Not classified | Z-1004-2007 | Other | Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in… |
| Jul 1, 2004 | Not classified | Z-1003-2007 | Other | Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in… |
The 5 latest of 45 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K953901 (3M Health Care, Sarns, 1996) has gone furthest, with 29 descendants of its own.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTQ
3in 2023
2007high 3 (2009) · low 0 (2012)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
2007high 292 (2023) · low 86 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
2007high 42 (2012) · low 0 (2015)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
2007high 1,626 (2012) · low 420 (2007)2025
MAUDE reports naming product code DTQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915183: Sarns 8000 Modular Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915183
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026