—#98620

Product

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. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity

FDA product code: DTR — Heat-Exchanger, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K900640
Affected lot / code info: Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 report the defect and arrange return of the unit: 800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Timeline

Recall initiated: 2011-03-01
Posted by FDA: 2014-10-31
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98620. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.