BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 11457639 · Received March 10, 2021

    Report

    Report Number
    3010617000-2021-00240
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 13, 2021
    Report Date
    March 10, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE THEMOGARD CONSOLE (SN UKNOWN) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AFTER 4 HOURS AND 20 MINS OF IVTM THERAPY, THE SALINE BAG WAS OBSERVED TO DECREASE IN VOLUME, NO LEAK WAS OBSERVED ON THE SUK AND THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM DURING LEAK CHECK. AFTER 10 MINUTES, THE PHYSICIAN SUSPECTED A QUATTRO CATHETER (LOT# 142198) LEAK AND THE IVTM THERAPY WAS DISCONTINUED. ADJUNCT THERAPY WAS USED TO CONTINUE TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2021-00193 FOR QUATTRO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354181 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 UNKNOWN 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1