BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS HEMOCARE

    MDR report key: 624785 · Received June 4, 2005

    Report

    Report Number
    MW1035645
    Event Type
    Injury
    Date Received
    June 4, 2005
    Date of Event
    April 15, 2005
    Report Date
    June 4, 2005
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EIGHTEEN MINS INTO A ROUTINE PLASMAPHERESIS TREATMENT USING AS104 CENTRIFUGE BASED MACHINE, THE CENTRIFUGE FELL OUT FROM THE DISK HOLDER, HIT THE BASIN AND SHATTERED. NO WARNING PRECEDED THE EVENT. AS A RESULT THE PT LOST 160CC OF BLOOD AND WITHOUT QUICK INTERVENTION BY THE PLASMAPHERESIS NURSE COULD HAVE SUFFERED A WORSE FATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HEMOCARE AS104 PLASMA SEPARATOR LKN FRESENIUS HEMOCARE, INC. AS104/95 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening