# K915183: Sarns 8000 Modular Perfusion System - Pathway: 510(k) (Traditional) - Applicant: 3M Health Care, Sarns - Decided: Jul 8, 1992 after 233 days - Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass) - Device class: 2 - Regulation: 21 CFR 870.4220 - Recalls of this device: 45 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 31 later devices descend from it; 3 cite it directly. 3 of 32 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA has not posted a summary or statement for it, so its predicates are not known. ## Most influential descendants - K953901: Sarns 800 Roller Pump (1996), 29 descendants of its own - K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch (2003), 26 descendants of its own - K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color, (2011), 8 descendants of its own - K052555: Medtronic Performer TM CPB, Model R51, PCPB (2006), 8 descendants of its own - K131041: Advanced Perfusion System 1 (2014), 6 descendants of its own ## Recalls of this device - Sep 25, 2012 · Class II · Z-0130-2013: 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 - Sep 25, 2012 · Class II · Z-0128-2013: 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 - Sep 25, 2012 · Class II · Z-0129-2013: 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 - Sep 25, 2012 · Class II · Z-0126-2013: 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 - Sep 25, 2012 · Class II · Z-0127-2013: 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 - Sep 25, 2012 · Class II · Z-0131-2013: 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 - Sep 25, 2012 · Class II · Z-0281-2013: 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 m - Sep 25, 2012 · Class II · Z-0285-2013: 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 m - Sep 25, 2012 · Class II · Z-0280-2013: 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 m - Sep 25, 2012 · Class II · Z-0282-2013: 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 m - Sep 25, 2012 · Class II · Z-0283-2013: 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 m - Sep 25, 2012 · Class II · Z-0284-2013: 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 m - Jun 20, 2012 · Class III · Z-2218-2012: 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 incorr - Jun 18, 2012 · Class II · Z-2045-2012: 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 express - Jun 18, 2012 · Class II · Z-2046-2012: 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 express - Jun 18, 2012 · Class II · Z-2047-2012: 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 express - Jun 18, 2012 · Class II · Z-2048-2012: 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 express - Jun 18, 2012 · Class II · Z-2044-2012: 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 express - Jun 18, 2012 · Class II · Z-2049-2012: 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 express - Mar 21, 2012 · Not classified · Z-1450-2012: 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 cau - Mar 21, 2012 · Not classified · Z-1452-2012: 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 cau - Mar 21, 2012 · Not classified · Z-1453-2012: 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 cau - Mar 21, 2012 · Not classified · Z-1451-2012: 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 cau - Oct 21, 2011 · Not classified · Z-0303-2012: 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 - May 3, 2011 · Not classified · Z-2614-2011: 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 ch - May 3, 2011 · Not classified · Z-2620-2011: 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 ch - May 3, 2011 · Not classified · Z-2613-2011: 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 ch - May 3, 2011 · Not classified · Z-2615-2011: 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 ch - May 3, 2011 · Not classified · Z-2621-2011: 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 ch - May 3, 2011 · Not classified · Z-2618-2011: 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 ch - May 3, 2011 · Not classified · Z-2616-2011: 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 ch - May 3, 2011 · Not classified · Z-2619-2011: 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 ch - May 3, 2011 · Not classified · Z-2617-2011: 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 ch - Nov 2, 2010 · Not classified · Z-0562-2011: The system 8000 roller pumps may fail resulting in a persistent pump stop. - Nov 2, 2010 · Not classified · Z-0563-2011: The system 8000 roller pumps may fail resulting in a persistent pump stop. - Aug 12, 2009 · Class II · Z-2348-2012: 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 ma - Sep 14, 2006 · Not classified · Z-0238-2007: The hand crank handle may separate and detach from the unit during use. - Sep 14, 2006 · Not classified · Z-0241-2007: The hand crank handle may separate and detach from the unit during use. - Sep 14, 2006 · Not classified · Z-0236-2007: The hand crank handle may separate and detach from the unit during use. - Sep 14, 2006 · Not classified · Z-0237-2007: The hand crank handle may separate and detach from the unit during use. - Sep 14, 2006 · Not classified · Z-0239-2007: The hand crank handle may separate and detach from the unit during use. - Sep 14, 2006 · Not classified · Z-0240-2007: The hand crank handle may separate and detach from the unit during use. - Jul 1, 2004 · Not classified · Z-1002-2007: 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 ma - Jul 1, 2004 · Not classified · Z-1004-2007: 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 ma - Jul 1, 2004 · Not classified · Z-1003-2007: 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 ma Source page: https://510kreport.com/device/K915183 Methodology: https://510kreport.com/methodology