MAUDE Adverse Event Report: CARDIAC SURGERY MFG KERKRADE PERFUSION TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number M449102D

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use the customer noticed a leak with the cardioplegia y-connector.The product was cut out and replaced.There was no patient involved so no adverse effect occurred.

• Brand Name: PERFUSION TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer (Section G): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8159648
• MDR Text Key: 130189078
• Report Number: 6000033-2018-00014
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K803277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: M449102D
• Device Catalogue Number: M449102D
• Device Lot Number: 215619425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2184009-11-30-2018-003-R
• Patient Sequence Number: 1