BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 12425965 · Received September 3, 2021

    Report

    Report Number
    3010617000-2021-00854
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 3, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMOGARD CONSOLE USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED TO ZOLL FOR EVALUATION. AFTER THE REPORTED EVENT, THE THERMOGARD CONSOLE WAS TESTED WITH A TRAINING START-UP KIT (SUK), AND NO DEVICE MALFUNCTION WAS NOTED. THE THERMOGARD CONSOLE WAS PLACED BACK ON THE FLOOR FOR FURTHER CLINICAL USE. THEREFORE, NO DEVICE EVALUATION AND SERVICE WILL BE PERFORMED BY ZOLL.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT IVTM THERAPY FOR FEVER CONTROL. AN ICY CATHETER (LOT # 160907) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 39.0 °C, AND THE TARGET TEMPERATURE WAS SET AT 37.5 °C, ON FEVER CONTROL RATE. DURING THE COOLING PHASE OF THE TREATMENT, THE THERMOGARD CONSOLE (S/N (B)(4)) GENERATED AN "AIR TRAP" ALARM. FOLLOWING THE ALARM, THE USER NOTICED THAT THE 500-ML SALINE BAG WAS EMPTY. THE DWELL TIME OF THE CATHETER WAS 70 HOURS, AND THE PATIENT'S BODY TEMPERATURE WAS AT 37.6 °C WHEN THE ISSUE WAS NOTED. UPON INSPECTION, THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR ON THE FLOOR. THE CUSTOMER SUSPECTED A CATHETER LEAK AND INFUSION OF 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE CATHETER WAS NOT REPLACED, AND NO FURTHER INFORMATION WAS PROVIDED REGARDING THE DETAILS OF THE TREATMENT AND HOW IT WAS COMPLETED. AS REPORTED, THE CUSTOMER WAS UNABLE TO CLEAR THE "AIR TRAP" ALARM. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00790 FOR THE ICY CATHETER (LOT # 160907).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321826 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR