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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC PERFUSION CUSTOM TUBING PACKS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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MEDTRONIC MEDTRONIC PERFUSION CUSTOM TUBING PACKS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 219237962, 220104289
Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
Some individual devices contained within the affected medtronic perfusion tubing packs were manufactured and distributed without device-level bacterial endotoxin testing.These results are necessary to support the non-pyrogenic label claim.Evaluation of the existing manufacturing controls and historical data suggest that the affected devices likely meet the requirement to be non-pyrogenic; however, due to the lack of data required to support the non-pyrogenic label claim, medtronic recalled the 165 lots of medtronic perfusion tubing packs.
 
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Brand Name
MEDTRONIC PERFUSION CUSTOM TUBING PACKS
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key13017692
MDR Text Key282342618
Report Number13017692
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number219237962, 220104289
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2021
Event Location Hospital
Date Report to Manufacturer12/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/16/2021
Type of Device Usage Unknown
Patient Sequence Number1
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