Recall Z-1027-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
| Date | Jan 27, 2023 (initiated Dec 12, 2022) |
| Status | Open, Classified |
| Reason | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit. |
| Root cause | Process change control |
| Action | Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection duri |
| Quantity | 63,278 units |
| Distribution | Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Den |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System Medtronic, Sep 16, 2021 |