BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 17128549 · Received June 14, 2023

    Report

    Report Number
    1649914-2023-00018
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 14, 2023
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY QUEST MEDICAL, INC. ON 05/26/2023. VISUAL INSPECTION CONFIRMED THE PRESENCE OF BLOOD ON THE TOP FLANGE OF THE HEAT EXCHANGER. IT WAS ALSO NOTED THAT THE BELLOW WITHIN THE HEX HAD A DEEP INDENTATION IN ITS NECK WHERE THE BLOOD POOLED. THE ROOT CAUSE WAS INFERRED TO BE DUE TO THE DEEP NECK DURING MOLDING BY THE SUPPLIER, LEADING TO INADEQUATE GLUE APPLICATION TO PREVENT LEAKAGE. QUEST WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION. QUEST HAS CONCLUDED ITS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE SAMPLE HAS BEEN RECEIVED, BUT ANALYSIS OF THE SAMPLE HAS NOT YET BEEN COMPLETED TO DATE. QUEST WILL FILE A SUPPLEMENTAL REPORT AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) OF AN ALLEGED ISSUE WITH PRODUCT CODE 5001102. IN THE REPORT, IT WAS STATED THAT BLOOD WAS ALLEGEDLY OBSERVED IN THE HEAT EXCHANGER. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS. LOT NUMBER OF THE DEVICE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230422 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown