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
This recall has been terminated (originally issued October 31, 2014).
- Recall Initiated
- March 1, 2011
- Posted
- October 31, 2014
- Terminated
- November 6, 2014
- Recall Number
- Z-0156-2015
- Quantity
- 596 units; 876 units
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
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
Root Cause
Device Design
Action Taken
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.