BEUDAMED
    FDA Adverse Event Summary report: N

    HOWES LARGE BORE MULTI-LUMEN CENTRAL VEIN CATHETERIZATION KT

    MDR report key: 17449 · Received November 7, 1994

    Report

    Report Number
    MW1003920
    Date Received
    November 7, 1994
    Date of Event
    October 21, 1994
    Report Date
    October 31, 1994
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    LFK
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TRIALYSIS CATHETERS WERE INSERTED BILATERALLY INTO FEMORAL VEINS. THESE CATHETERS WERE CONNECTED TO A CAVH FILTER. AFTER BEGINNING THE CAVH, THE NURSE NOTICED A SLIGHT BLOOD LEAK AT THE TRIALYSIS LIMB ADAPTER CONNECTION. CAVH WAS STOPPED, A MEDICAL RESIDENT CAME DOWN, CUT OFF THE END OF THE LIMB OF THE CATHETER AND ATTACHED A NEW ADAPTER FROM ANOTHER TRIALYSIS KIT. THIS CORRECTED THE PROBLEM, HOWEVER, THE CAVH FILTER COULD NOT BE SALVAGED. BEFORE A NEW CAVH FILTER COULD BE PRIMED, THE PT ARRESTED AND SUBSEQUENTLY DIED DESPITE RESUSCITATION ATTEMPTS. THIS PT WAS IN CRITICAL CONDITION WITH MULTISYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWES LARGE BORE MULTI-LUMEN CENTRAL VEIN CATHETERIZATION KT LFK ARROW INTERNATIONAL, INC. AK-1-234-4

    Patients

    Seq Age Sex Outcome Treatment
    1 *