Recall Z-2961-2020 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
| Date | Aug 25, 2020 |
| Status | Terminated |
| Reason | 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 connector. This intermittent connection may result in false air bubble alarms. |
| Root cause | Employee error |
| Action | Urgent Medical Device Removal notification letters dated 8/25/20 were sent to customers. Terumo CVS is removing the affected ABD sensors from the field. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement device and subsequent return of the affected unit. The replacement ABD sensor supplied by Terumo CVS will be part of a kit containing a cable and a bracket which are not affected by this removal. The cable and the bracket do not require replacement. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Correction and assure that all users have re |
| Quantity | 2 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| 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 |