Recall Z-3242-2018 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
| Date | Aug 28, 2018 |
| Status | Terminated |
| Reason | 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 go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system. |
| Root cause | Process control |
| Action | Terumo CVS issued letter on 8/2/818 via Fed'X 2 day air to inform users of the problem for the Power Manager boards with unverifiable or out of specification screws, potential hazard and field correction. A Terumo Field Service Representative will contact users to schedule the field correction activities. Terumo CVS Customer Service: 1.800.521.2818, Monday Friday, 8 a.m. 6 p.m. ET |
| Quantity | 47 units |
| Distribution | Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam |
| 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 |