BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII (NO DRN) PKG/6 W/CAPACITOR

    MDR report key: 1791554 · Received July 26, 2010

    Report

    Report Number
    2648666-2010-00321
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE LOT NUMBER PROVIDED DOES NOT MATCH THE LOT NUMBERING SCHEME USED BY THE MANUFACTURER, SO A DEVICE HISTORY REVIEW CANNOT BE DONE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLECTED BLOOD COAGULATED AND COULD NOT BE RE-INFUSED. THE ACCOUNT USED A BACK UP DEVICE TO COLLECT AND RE-INFUSE THE BLOOD. THERE IS NO ALLEGATION THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION FROM EITHER A BLOOD BANK OR PRE-DONATED BLOOD. THERE ARE NO ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII (NO DRN) PKG/6 W/CAPACITOR AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK