BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC

    MDR report key: 1935587 · Received December 14, 2010

    Report

    Report Number
    2648666-2010-00493
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE Y-CONNECTOR. THE COLLECTED BLOOD WAS RE-INFUSED TO THE PT AND THERE WAS NO REPORT OF EXPOSURE. 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/1/8 INCH ROUND PVC AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO 10284012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK