| Date Initiated by Firm | August 28, 2018 |
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| Create Date | September 25, 2018 |
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| Recall Status1 |
Terminated 3 on April 23, 2020 |
| Recall Number | Z-3242-2018 |
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| Recall Event ID |
80957 |
| 510(K)Number | K172220 |
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| Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
|
| Product | Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Catalog Number 801763 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Process control |
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| 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 |
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| Quantity in Commerce | 47 units |
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| Distribution | Nationwide
Foreign:
Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DTQ
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