BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENWAL COLLECTION BAG

    MDR report key: 1151964 · Received September 5, 2008

    Report

    Report Number
    MW5008224
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 5, 2008
    Manufacturer
    FENWAL, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNIT OF BLOOD COLLECTED IN BAG, PRODUCT LOT NUMBER FM08D14054, IN 2008 AT CHOC BLOOD AND DONOR SERVICES. DURING PRODUCT PROCESSING AT HOSPITAL BLOOD BANK ON THE SAME DAY, IT WAS NOTICED THAT BAG TUBING WAS NOT CONNECTED TO PLASMA BAG. HOSPITAL BLOOD BANK USED A TRANSFER PACK AND STERILE DOCKING DEVICE TO EXPRESS PLASMA AND PRODUCE A USEABLE RED-CELL UNIT. HOSPITAL BLOOD BANK DISCARDED ORIGINAL PLASMA BAG. FOURTH OCCURRENCE SINCE SEVEN MONTHS EARLIER. ALL EVENTS AND LOT NUMBERS REPORTED TO FENWAL -MANUFACTURER- AT TIME OF OCCURRENCE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: COLLECTION OF DONOR BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENWAL COLLECTION BAG UNIT COLLECTION BAG KSR FENWAL, INC. 2BA04R3337 FM08D14054

    Patients

    Seq Age Sex Outcome Treatment
    1