BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 14571052 · Received June 2, 2022

    Report

    Report Number
    3010617000-2022-00540
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 8, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE THERMOGARD XP IVTM SYSTEM (SN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A COMPLAINT THAT "THE THERMOGARD XP IVTM SYSTEM SN (B)(6) GENERATED AN "AIR TRAP WARMING" ALARM" WAS CONFIRMED BASED ON THE EVENT LOG REVIEW. THIS ALARM OCCURS IF THE LEVEL OF THE SALINE IN THE AIR TRAP RESERVOIRS FALLS BELOW ACCEPTABLE LEVELS DURING RUN. THE ROOT CAUSE FOR THE REPORTED "AIR TRAP WARNING" ALARM WAS THE SALINE LEAK FROM THE START-UP KIT'S (SUK) LFL TUBING CAUSED BY A NARROW GAP IN THE PUMP RACEWAY. THE CUSTOMER REPORTED A COMPLAINT THAT "AN OCCASIONAL SQUEAKING NOISE WAS NOTED FROM THE THERMOGARD XP IVTM SYSTEM," WHICH WAS CONFIRMED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING. UPON VISUAL INSPECTION, ZOLL SERVICE PERSONNEL NOTED THAT WHITE ROLLERS ARE DAMAGED AND FALLEN OUT OF THE ROTARY HEAD, THE ROLLER GAPS ARE NARROW, AND THE ROLLERS ON THE ROTARY HEAD ARE HARD TO ROTATE; THUS, CONFIRMING THE REPORTED COMPLAINT OF SQUEAKING NOISE. UPON FURTHER VISUAL INSPECTION, ZOLL SERVICE PERSONNEL NOTED SALINE SPILLED IN THE PUMP RACEWAY AND ON THE DRIP TRAY, INDICATING A SUK LEAK. THE EVENT LOG REVIEW INDICATED THE OCCURRENCE OF AN EVENT ALARM 1.5.0 (ALARM "AIR TRAP WARNING") ON THE CUSTOMER'S REPORTED EVENT DATE, THUS, CONFIRMING THE REPORTED COMPLAINT. THE THERMOGARD SYSTEM FAILED THE PUMP ROLLER CLEARANCE VERIFICATION TEST DURING FUNCTIONAL TESTING. THE ROTOR HEAD GAPS WERE CLEANED, SILICONE LUBRICATED AND READJUSTED TO ADDRESS THE OBSERVED PROBLEM. AFTER CALIBRATING THE ROTARY HEAD, THE THERMOGARD SYSTEM PASSED THE FUNCTIONAL AND FLOW RATE TESTS. FOLLOWING WHITE GUIDE ROLLER REPLACEMENT AND SERVICE, THE THERMOGARD XP IVTM SYSTEM PASSED ALL THE FINAL FUNCTIONAL TESTS WITHOUT ERROR. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO SIMILAR COMPLAINT WAS REPORTED FOR THERMOGARD XP IVTM SYSTEM WITH SN (B)(6).

    Description of Event or Problem · 0

    DURING THE MAINTENANCE PHASE OF THE IVTM THERAPY, THE CUSTOMER NOTED SALINE ON THE FLOOR AROUND THE THERMOGARD XP IVTM SYSTEM (SN (B)(4), AN EMPTY SALINE BAG, AND THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP WARMING" ALARM. IN ADDITION, THE CUSTOMER NOTED SALINE ADJACENT TO THE START-UP KIT'S (SUK) LFL TUBING. THE CUSTOMER STATED THAT OCCASIONAL SQUEAKING NOISE WAS NOTED WHILE THE SUK'S LFL TUBING ROTATED PRIOR TO THE SUK LEAK. THE DWELL TIME OF THE SUK IS UNKNOWN. THE CUSTOMER REPLACED THE SUK AND THE SALINE BAG, AND THE PATIENT'S TEMPERATURE WAS MAINTAINED USING ANOTHER THERMOGARD SYSTEM. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. BASED ON THE PICTURES PROVIDED BY THE CUSTOMER, THERE APPEARS TO BE A SCRATCH OR SCUFF ON THE LFL TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215451 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown