BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO CAVH KIT

    MDR report key: 7073 · Received October 26, 1993

    Report

    Report Number
    7073
    Event Type
    Death
    Date Received
    October 26, 1993
    Date of Event
    October 24, 1993
    Report Date
    October 26, 1993
    Manufacturer
    CGH MEDICAL
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FEMORAL ARTERY LINE FOUND DISCONNECTED FROM CANNULA. PT ARRESTED POST EXCESSIVE BLOOD LOSS. DEVICE IN PLACE 28 HRS PRIOR TO EVENT AND CONNECTION WAS UNDER DRESSING.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CAVH KIT CONTINUOUS ARTERIO-VENOUS HEMOFILTRATION DEVICE KDI CGH MEDICAL FH55/G514KV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death