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U.S. Department of Health and Human Services

Class 2 Device Recall Modified MP4Cardioplegia Delivery System with Conducer

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  Class 2 Device Recall Modified MP4Cardioplegia Delivery System with Conducer see related information
Date Initiated by Firm March 01, 2011
Date Posted October 31, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0156-2015
Recall Event ID 58185
510(K)Number K900640  
Product Classification Heat-exchanger, cardiopulmonary bypass - Product Code DTR
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
Code Information 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
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact Same
508-231-2400
Manufacturer 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
FDA Determined
Cause 2		 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 report the defect and arrange return of the unit: 800-521-2818.
Quantity in Commerce 596 units; 876 units
Distribution Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DTR and Original Applicant = 3M COMPANY
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