BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 13609084 · Received February 26, 2022

    Report

    Report Number
    3010617000-2022-00241
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    January 15, 2022
    Report Date
    February 25, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE THERMOGARD XP IVTM SYSTEM 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 · 0

    THE START-UP KIT (SUK) (LOT #172206) WAS CONNECTED TO THE THERMOGARD XP IVTM SYSTEM, AND PRIMING WAS PERFORMED TO INITIATE THE IVTM THERAPY FOR A (B)(6)-YEAR-OLD FEMALE PATIENT (WEIGHT - (B)(6) LBS.). AN ICY CATHETER (LOT #UNKNOWN) WAS USED FOR THE IVTM THERAPY. AFTER AN UNKNOWN PERIOD, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) GENERATED AN AIR TRAP ALARM, AND MANY AIR BUBBLES WERE NOTED IN THE SUK AIR TRAP. THE USER OBSERVED AN EMPTY SALINE BAG AND BLOOD TINGE ON THE SUK TUBING, INDICATING A POTENTIAL CATHETER LEAK. THE CUSTOMER DISCARDED THE CATHETER AND THE SUK. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. FOR THE ABOVE-REPORTED EVENT, ZOLL RECEIVED MEDWATCH REPORT #(B)(4) ON (B)(6) 2022. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00192 FOR THE ICY CATHETER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358431 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female