BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 4875687 · Received June 29, 2015

    Report

    Report Number
    1649914-2015-00047
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 15, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSIS. THERE WERE NO DEVICES OF THIS SAME LOT REMAINING IN INVENTORY FOR EVALUATION. THE ROOT CAUSE OF THE ALLEGED LEAK IS UNKNOWN; HOWEVER, THERE IS AN OPEN CPAR TO ADDRESS THE COMPLAINT CONDITION. IT IS KNOWN THAT IF THE CHECK VALVE IS NOT SUFFICIENTLY TIGHTENED THEN A LEAK IS POSSIBLE. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHILE USING THE MPS DELIVERY SET. IT WAS REPORTED TO THEM BY THE HOSPITAL PERFUSIONIST THAT THERE WERE NO ISSUES SEEN DURING PRIMING, BUT THAT AFTER CIRCULATION OF CARDIOPLEGIA STARTED LEAKS WERE SEEN FROM THE LUER CONNECTOR OF THE DRUG SOLUTION SIDE (THE ADDITIVE SIDE). THE DRUG SOLUTION BEING ADMINISTERED WAS NOT REPORTED. THE HOSPITAL REPORTED THAT BECAUSE THE LEAK WAS VERY SMALL THEY CONTINUED TO USE THE DELIVERY SET THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISTRIBUTOR REPORTED THAT THE HOSPITAL DISCARDED THE DELIVERY SET SAMPLE BUT THEY DID DOCUMENT THE APPLICABLE LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417829 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0483815F02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention