# K871131: Sarns 9000 Heart-Lung Console

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: May 21, 1987 after 62 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
3 of 33 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
- K953904: Sarns 9000 Universal 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
- Jun 18, 2012 · Class II · Z-2052-2012: 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-2051-2012: 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-2050-2012: 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
- 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
- May 23, 2008 · Not classified · Z-0295-2009: The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
- May 23, 2008 · Not classified · Z-0296-2009: The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.

Source page: https://510kreport.com/device/K871131
Methodology: https://510kreport.com/methodology