BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 10467430 · Received August 28, 2020

    Report

    Report Number
    1649914-2020-00031
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 28, 2020
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K173716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT NUMBER 0601210M08 WAS REVIEWED, AND THE INSPECTION REPORT SHOWS THAT NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THIS COMPLAINT CONDITION. IN ADDITION, AS THE REPORTED ISSUE IS RELATED TO THE HEAT EXCHANGER, SUB ASSEMBLY DEVICE HISTORY RECORD FOR 801082 LOT NUMBER 0599680057 AND 0600670058 WERE ALSO REVIEWED, AND THE INSPECTION REPORT SHOWS THAT NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO COMPLAINT CONDITION. AN INVESTIGATION COULD NOT BE COMPLETED BECAUSE THE ALLEGED SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AN INCIDENT WAS REPORTED WHERE THE REPORTER EMAILED A PICTURE TO CUSTOMER SERVICE. THE REPORTER SAID THAT THEY NOTICED BLOOD MIGRATION INTO THE HEAT EXCHANGER IN A WAY THEY HAD NOT SEEN BEFORE. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931409 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0601210M08 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1