BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 15233899 · Received August 16, 2022

    Report

    Report Number
    3010617000-2022-01346
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT YET RECEIVED THE DEVICE IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IVTM THERAPY WAS STARTED FOR A NEURO PATIENT TO COOL THEM. AFTER A FEW HOURS, THE CUSTOMER NOTICED THE VOLUME OF THE SALINE BAG (500ML) WAS DECREASING. DURING THE NIGHT, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) DISPLAYED AN AIR TRAP ALARM AND THERE WAS SALINE OBSERVED IN THE AIR TRAP HOLDER AND AROUND THE CONSOLE. NO BLOOD WAS OBSERVED IN THE TUBING OF THE START-UP KIT (SUK) (LOT #UNKNOWN) AND THE LOCATION OF THE LEAK IS UNKNOWN. IT IS UNKNOWN IF THE ALARM WAS CLEARED. THE CUSTOMER REPLACED THE SALINE BAG AND SUK AND SWITCHED THE THERMOGARD XP IVTM SYSTEM, BUT THE SALINE BAG STILL DEPLETED. THE CUSTOMER SUSPECTS THE ICY CATHETER (LOT #170133) HAS A LEAK. NO DEVICE MALFUNCTION WAS REPORTED WITH THE SECOND SUK OR CONSOLE. THE PATIENT WAS DISCONNECTED FROM THE THERMOGARD AND ARCTIC SUN WAS USED INSTEAD. UPON FOLLOW UP, THE CUSTOMER REPORTED THE SUK AND CATHETER WERE DISCARDED AND WILL NOT BE RETURNED. NO CONSEQUENCE OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: PLEASE SEE THE FOLLOWING RELATED MFR REPORT:MFR #3010617000-2022-01112 FOR THE ICY CATHETER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013137 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION INC 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown