BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD XP®

    MDR report key: 20861223 · Received December 6, 2024

    Report

    Report Number
    3010617000-2024-00976
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL SERVICE EVALUATED THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) AT THE CUSTOMER SITE. THE REPORTED COMPLAINT THAT THE THERMOGARD SYSTEM COULD NOT ACHIEVE THE REWARMING TARGET TEMPERATURE WAS CONFIRMED IN THE SYSTEM'S PATIENT TREATMENT DATA LOG BUT WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. NO DEVICE MALFUNCTION WAS FOUND, AND THE THERMOGARD CONSOLE FUNCTIONED AS INTENDED. BASED ON THE ANALYSIS OF THE PATIENT DATA LOG FILES, THE REPORTED ISSUE OCCURRED POSSIBLY DUE TO THE PATIENT BEING SIMULTANEOUSLY ON AN ECMO DEVICE, WHICH CIRCULATES A SIGNIFICANTLY HIGHER VOLUME OF BLOOD, THEREBY OVERPOWERING THE THERMOGARD SYSTEM'S WARMING EFFORTS. A REVIEW OF THE SYSTEM'S EVENT LOG DATA SHOWED NO HARDWARE ERROR CODES AROUND THE REPORTED EVENT DATE. HOWEVER, THE PATIENT TREATMENT DATA LOG INDICATED THAT THE PATIENT'S TEMPERATURE DID NOT MAINTAIN THE SET WARMING TARGET OF 36.5°C THROUGHOUT THE THERAPY, CONFIRMING THE CUSTOMER'S COMPLAINT. THIS ISSUE MAY HAVE BEEN DUE TO THE PATIENT BEING ON AN ECMO DEVICE, WHICH CIRCULATES A SIGNIFICANTLY HIGHER VOLUME OF BLOOD, POTENTIALLY OVERPOWERING THE THERMOGARD SYSTEM'S WARMING EFFORTS. ACCORDING TO THE PATIENT TREATMENT DATA LOG, REWARMING THE PATIENT WITH THE THERMOGARD WAS SUPPLEMENTED WITH AN EXTERNAL HEAT BLOWER APPROXIMATELY 15 HOURS INTO THE TREATMENT. THE TARGET TEMPERATURE OF 36.5°C WAS MAINTAINED FOR ABOUT 11 HOURS. HOWEVER, THE PATIENT'S TEMPERATURE FELL BELOW THE TARGET DURING THE LAST 10 HOURS OF THE TREATMENT. CONSEQUENTLY, THE CUSTOMER DISCONTINUED IVTM AND SWITCHED THE PATIENT TO A SURFACE TEMPERATURE MANAGEMENT SYSTEM. THE THERMOGARD XP IVTM SYSTEM PASSED THE INITIAL FUNCTIONAL TESTING WITHOUT ISSUES OR FAULTS. FOLLOWING SERVICE, THE THERMOGARD SYSTEM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 0

    A PATIENT WHO HAD UNDERGONE ELECTIVE CARDIAC BYPASS SURGERY WAS INDUCED FOR HYPOTHERMIA USING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE. THE THERMOGARD XP IVTM SYSTEM (SN (B)(6), A PRIMARY TEMPERATURE PROBE, AND A COOL LINE CATHETER WERE THEN EMPLOYED TO REWARM THE PATIENT IN CONJUNCTION WITH THE ECMO DEVICE, AIMING TO MAINTAIN NORMOTHERMIA AT 36.5°C. THE TARGET TEMPERATURE OF 36.5°C AND MAX WARMING MODE WERE SET ON THE THERMOGARD SYSTEM TO WARM THE PATIENT. THE CUSTOMER REPORTED THAT THE THERMOGARD CONSOLE WAS UNABLE TO ACHIEVE THE TARGET TEMPERATURE, AND THE DOCTOR DECIDED TO ADD AN EXTERNAL HEATING DEVICE AND USE SURFACE TEMPERATURE CONTROL. THE CUSTOMER STATED THAT THE PINWHEEL OF THE START-UP KIT (SUK) WAS ROTATING DURING THE TREATMENT, INDICATING NO KINKS, BENDS, OR OCCLUSIONS. THERE WERE NO REPORTED ISSUES WITH THE COOL LINE CATHETER USED FOR REWARMING. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245411 THERMOGARD XP® INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM NCX ZOLL CIRCULATION, INC. THERMOGARD XP, LANG SET A, NON-ROHS 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown