Recall Z-0156-2015 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additio
| Date | Oct 31, 2014 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line |
| Root cause | Device Design |
| Action | Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to rep |
| Quantity | 596 units; 876 units |
| Distribution | Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900640 | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU 3M Company, Apr 20, 1990 |