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

Model Number M446913F

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

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 during priming of the custom tubing pack it was noted that there were holes in the parallel y connector.The pack was replaced.There was no adverse effect on the patient.

Manufacturer Narrative

The event date submitted in the original emdr is year valid only as 15 additional devices were found to have the same issue and the exact event dates are not available for the 15 additional occurrences.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: visual inspection of the 16 returned connectors shows evidence of a crack/damage at the base of the "y" connector.Additional visual inspection shows all 16 are from mold cavity 1.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8136927
• MDR Text Key: 129608036
• Report Number: 6000033-2018-00007
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K803277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: M446913F
• Device Catalogue Number: M446913F
• Device Lot Number: 215713338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2184009-11-30-2018-003-R
• Patient Sequence Number: 1