BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 17779319 · Received September 20, 2023

    Report

    Report Number
    3010617000-2023-00805
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 27, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S BIOMED ENGINEER ATTEMPTED TO ADJUST THE ROTOR GAP, WHICH LIKELY DAMAGED THE LFL TUBING AND CAUSED BOTH START-UP KITS (SUK) TO LEAK. THE THERMOGARD CONSOLE INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED TO A ZOLL SERVICE DEPOT FOR EVALUATION. THE REPLACEMENT ROLLER PUMP WAS ORDERED BY THE CUSTOMER AND WILL BE REPLACED TO ADDRESS THE REPORTED COMPLAINT. THEREFORE, SERVICE WAS NOT REQUIRED TO BE PERFORMED BY ZOLL.

    Description of Event or Problem · 0

    DURING THE IVTM THERAPY, THE CUSTOMER OBSERVED A FLUID UNDER THE THERMOGARD CONSOLE (SN (B)(6)). PER THE REPORTER, THE CONSOLE DID NOT DISPLAY AN AIR TRAP ALARM, HOWEVER, THE SALINE BAG WAS REPLACED. THE CUSTOMER WAS INSTRUCTED TO REPLACE THE START-UP KIT (SUK) (LOT # 185593). LATER IN THE EVENING, THE CUSTOMER REPORTED THAT THE SECOND SUK (LOT # 191785) WAS LEAKING AS THE LFL TUBING OF THE SUK THAT WAS PLACED INSIDE OF THE ROLLER PUMP WAS "SHREDDED". THE CONSOLE AND THE SUK WERE REPLACED TO COMPLETE THE TREATMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589191 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown