BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 6302630 · Received February 3, 2017

    Report

    Report Number
    1649914-2017-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    December 19, 2016
    Report Date
    January 6, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT CONDITION WAS CONFIRMED. A LEAK WAS FOUND BETWEEN THE CLEAR HOUSING AND THE YELLOW HANDLE DIVERTER OF THE STOPCOCK IN THE DELIVERY POSITION. THE STOPCOCK IS OBTAINED FROM AN OUTSIDE SUPPLIER, WHO WAS NOTIFIED AND ISSUED A SCAR TO ADDRESS THE ISSUE. 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. THERE WERE NO MORE DEVICES OF THIS SAME LOT REMAINING IN INVENTORY FOR EVALUATION. 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 THEIR CUSTOMER ENCOUNTERED WHILE USING THE DELIVERY SET. THE REPORT STATED THAT DURING AN EMERGENCY SURGERY, THE BACKSIDE OF THE THREE-WAY STOPCOCK OF THE ARREST POUCH CONTAINING POTASSIUM LEAKED. THE REPORT STATED THE CLINICIANS DECIDED TO USE THE DELIVERY SET TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83673 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0513606Y07 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention