—#167118

Product

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K172220
Affected lot / code info: Serial Numbers: 0386 1481 1497 1509 1526 1529 1531 1532 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1561 1562 1563 1564 1565 1566 1570 1597 1612 1630 1631 1640 1641 1649 1547 1560 1559 1567 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03130 , 03308

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam

Timeline

Recall initiated: 2018-08-28
Terminated: 2020-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.