Recall Z-1769-2019 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
| Date | Oct 17, 2018 |
| Status | Terminated |
| Reason | 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 the gas system can only be controlled by the local control knobs. |
| Root cause | Process control |
| Action | On October 17, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. The letter alerted customers that the devices were assembled with stepper motors that did not meet supplier specifications. Customers were informed that in the event of a failure, the gas system flow and FiO2 control sliders on the Central Control Monitor would be disabled and the gas system could only be controlled by the local control knobs. Customers were asked to take the following actions: 1. Review this Medical Device Correction and assure that all users have received notice of this |
| Quantity | 72 |
| Distribution | Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172220 | Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation, Aug 17, 2017 |