BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM SUK

    MDR report key: 13973489 · Received April 1, 2022

    Report

    Report Number
    3010617000-2022-00331
    Event Type
    Death
    Date Received
    April 1, 2022
    Date of Event
    August 24, 2021
    Report Date
    August 27, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K014241
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 25, 2021, THIS COMPLAINT WAS ASSESS AS A NON-REPORTABLE, HOWEVER, ON MARCH 1, 2022, DURING INVESTIGATION REVIEW, THIS COMPLAINT IS REASSESS AND CONSIDERED TO BE A REPORTABLE. THE SUK ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS DISPOSED BY THE CUSTOMER. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. IVTM THERAPY WAS COMPLETED. USUALLY CRITICALLY ILL PATIENTS RECEIVE IVTM THERAPY AND MORTALITY RATE IS HIGH. ADDITIONAL INFORMATION IS REQUESTED. IT IS LIKELY THAT OUTCOME DEATH RELATED TO THE PATIENT'S CLINICAL CONDITION AND NOT TO IVTM THERAPY. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). THE DEATH IS NOT RELATED TO DEVICE AND TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    FOLLOWING THE MEDICAL SAFETY ASSESSMENT, ZOLL CONCLUDED THAT THE DEATH WAS NOT RELATED TO THE START-UP KIT OR IVTM THERAPY, BUT RATHER TO THE PATIENT'S CLINICAL CONDITION. THEREFORE, SUBMITTING THIS SUPPLEMENTAL MDR TO RETRACT THE INITIAL MDR SUBMISSION.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER REPORTED THAT LIQUID WAS LEAKING UNDER THE THERMOGARD IVTM SYSTEM (SN: (B)(4)) AND ALSO THE START-UP KIT (LOT #UNKNOWN) WAS LEAKING. THE THERMOGARD IVTM SYSTEM DID NOT GENERATE AN ALARM OR DISPLAYED ANY ERROR MESSAGE. ANOTHER THERMOGARD IVTM SYSTEM TO CONTINUE, A NEW SUK AND COMPLETED THE TREATMENT. PATIENT DEATH WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2021-00916 FOR THE THERMOGARD IVTM SYSTEM (SN: (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653723 ZOLL IVTM SUK CENTRAL VENOUS START UP KIT NCX ZOLL CIRCULATION 8700-0784-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death