BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 6071388 · Received November 1, 2016

    Report

    Report Number
    1649914-2016-00051
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WERE NO MORE DEVICES OF THE SAME LOT REMAINING IN INVENTORY FOR EVALUATION. IT IS UNKNOWN IF THE REPORTED ISSUE WAS CAUSED BY IMPROPER HANDLING BY THE CUSTOMER (SUCH AS PRIMING OVERNIGHT) OR A MANUFACTURING 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. THE HEAT EXCHANGER DEVICE HISTORY RECORD SHOWED THAT THERE WERE 3 REJECTS FOR <50% COVERAGE (VISUAL DEFECT) FOUND IN PRODUCTION AND IN-PROCESS INSPECTION. 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 HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. HE REPORTED THAT TRACES OF BLOOD WERE OBSERVED ON THE SURFACE OF THE BELLOWS OF THE HEAT EXCHANGER. THE REPORT INDICATED THIS WAS FOUND AT THE END OF THE PROCEDURE WHILE WARMING. THE REPORT STATED THAT NO BLOOD WAS OBSERVED IN THE WATER SOURCE, NOR WAS WATER IN THE BLOOD SOURCE DETECTED. THE REPORT FURTHER STATED THE INCIDENT DID NOT CAUSE A DELAY IN THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DELIVERY SET WAS DISCARDED BY THE FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722673 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0517526U10 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention