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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SURGERY MFG KERKRADE PERFUSION PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS
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CARDIAC SURGERY MFG KERKRADE PERFUSION PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number M443207E
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2018
Event Type  malfunction  
Manufacturer Narrative
The event date is the (b)(6) 2018 "year valid" the exact event dates are not available for six of the seven occurrence but the customer has indicated that the occurrences took place between (b)(6) 2018.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-connectors.The affected products section were replaced.There was no patients involved so no adverse effect occurred.
 
Manufacturer Narrative
Visual analysis: visual inspection of all 7 devices show evidence of a crack/damage at the base of the "y" connector.Additional visual inspection shows all of the devices are from mold cavity 1.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PERFUSION 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 Key8160669
MDR Text Key130344482
Report Number6000033-2018-00016
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K803277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model NumberM443207E
Device Catalogue NumberM443207E
Device Lot Number215621288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2184009-11-30-2018-003-R
Patient Sequence Number1
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