BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD HQTM CONSOLE

    MDR report key: 23480674 · Received November 5, 2025

    Report

    Report Number
    3010617000-2025-00759
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. THE CUSTOMER'S COMPLAINT THAT THE START-UP KIT (SUK) LFL TUBING AROUND THE ROLLER PUMP RUPTURED, CAUSING SALINE TO SPURT FROM THE TUBING INTO THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE (SN (B)(6) WAS CONFIRMED DURING THE VISUAL INSPECTION. THE ROLLER PUMP KNOB ON THE CONSOLE WAS THE OLD TYPE, WHICH CAUSED THE SUK TUBE TO RUPTURE. UPON VISUAL INSPECTION, IT WAS CONFIRMED THAT NORMAL SALINE HAD ACCUMULATED IN THE PUMP RACEWAY. THE CONSOLE INTERIOR WAS ALSO INSPECTED, BUT NO INFILTRATION OF NORMAL SALINE WAS OBSERVED. THE SALINE TRACES WERE CLEANED, AND THE OLD ROLLER PUMP KNOB WAS REPLACED WITH THE NEW VERSION TO ADDRESS THE REPORTED COMPLAINT. FOLLOWING CLEANING AND PART REPLACEMENT, THE THERMOGARD HQ CONSOLE PASSED THE FUNCTIONAL TESTING WITHOUT ERROR. FOLLOWING SERVICE, THE THERMOGARD HQ CONSOLE PASSED THE FINAL FUNCTIONAL AND ELECTRICAL SAFETY TESTS WITHOUT ANY ISSUES. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE THERMOGARD HQ CONSOLE WITH SN (B)(6).

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE START-UP KIT (LOT # 200280) LFL TUBING AROUND THE ROLLER PUMP RUPTURED, CAUSING SALINE TO SPURT FROM THE TUBING INTO THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE (SN (B)(6). BECAUSE THE ROLLER PUMP WAS FILLED WITH SALINE, THE CUSTOMER STOPPED USING THE THERMOGARD HQ CONSOLE AND SWITCHED TO A SYSTEM FROM ANOTHER MANUFACTURER TO CONTINUE TEMPERATURE MANAGEMENT. THE ROLLER PUMP KNOB ON THE CONSOLE WAS OF THE OLD TYPE. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491799 THERMOGARD HQTM CONSOLE INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM NCX ZOLL CIRCULATION, INC. THERMOGARDHQ, LANG SET A 00849111075800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown