# K172220: Advanced Perfusion System 1

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Aug 17, 2017 after 24 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
Longest line of descent: 7 generations back to K915183 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163531: Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (2017) Summary page 4.

## Most influential descendants
- K221895: Terumo Advanced Perfusion System 1 (2023), 0 descendants of its own

## Recalls of this device
- Jun 8, 2021 · Class II · Z-2350-2021: intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monit
- Aug 25, 2020 · Class II · Z-2961-2020: Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire co
- Aug 25, 2020 · Class II · Z-2959-2020: Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire co
- Aug 25, 2020 · Class II · Z-2960-2020: Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire co
- Jan 10, 2020 · Class II · Z-1110-2020: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump oper
- Jan 10, 2020 · Class II · Z-1109-2020: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump oper
- Jan 10, 2020 · Class II · Z-1111-2020: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump oper
- Jan 10, 2020 · Class II · Z-1108-2020: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump oper
- Apr 18, 2019 · Class II · Z-1337-2019: The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
- Oct 17, 2018 · Class II · Z-1769-2019: An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that t
- Sep 13, 2018 · Class II · Z-0176-2019: The service manual was not updated at the time of the release of software version 1.30.
- Aug 28, 2018 · Class II · Z-3243-2018: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can
- Aug 28, 2018 · Class II · Z-3242-2018: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can
- Jan 19, 2018 · Class II · Z-1478-2018: Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation)

## Indications for use
The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

Source page: https://510kreport.com/device/K172220
Methodology: https://510kreport.com/methodology