BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC

    MDR report key: 1903016 · Received November 12, 2010

    Report

    Report Number
    2648666-2010-00453
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 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 RETURNED TO THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO HOLES IN THE BLOOD BAG WHEN THE COLLECTED BLOOD WAS TRANSFERRED. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. IT IS UNK IT THE PT REQUIRED A BLOOD TRANSFUSION FROM A BLOOD BANK OR PRE-DONATED BLOOD, BUT THERE WERE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK