BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II - (3/16" KIT) PKG/6 WORLD

    MDR report key: 1791609 · Received July 28, 2010

    Report

    Report Number
    2648666-2010-00332
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT, AND NO LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DROPPED IN THE OPERATING ROOM. WHEN THE TRANSFER LEVER WAS DEPRESSED AFTER COLLECTING THE BLOOD, THE INTERNAL PLUNGER WAS NOT FUNCTIONING. NONE OF THE COLLECTED BLOOD WAS RE-INFUSED. IT IS UNKNOWN HOW MUCH BLOOD HAD BEEN COLLECTED AND DISCARDED. IT IS ALSO UNKNOWN IF THE PATIENT RECEIVED A BLOOD TRANSFUSION FROM EITHER A BLOOD BANK OR PRE-DONATED BLOOD. ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION, BUT NONE WAS AVAILABLE FROM THE ACCOUNT. THERE WERE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II - (3/16" KIT) PKG/6 WORLD AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK