BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 4167416 · Received October 13, 2014

    Report

    Report Number
    1649914-2014-00049
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 21, 2014
    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

    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.

    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. THERE WERE NO DEVICES OF THIS SAME LOT REMAINING IN INVENTORY FOR ANALYSIS.

    Description of Event or Problem · 1

    THE FOREIGN DISTRIBUTOR ((B)(4)) REPORTED A LEAKAGE ISSUE WITH THE MPS DISPOSABLE DELIVERY SET FROM ONE OF THEIR CUSTOMERS. THE HOSPITAL HAD REPORTED A LEAKAGE FROM THE CONNECTION BETWEEN THE DRUG SOLUTION BAG (ADDITIVE) AND THE HEAT EXCHANGER. THE REPORTED STATED THE ALLEGED LEAK WAS DISCOVERED 45 MINUTES AFTER THE FIRST INSERTION OF CARDIOPLEGIA SOLUTION, WAS A SLOW LEAK, AND WAS A MIXTURE OF BLOOD AND THE DRUG SOLUTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED COMPLAINT. THE DELIVERY SET SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648431 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0469084E02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention