BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1970379 · Received January 18, 2011

    Report

    Report Number
    2648666-2011-00016
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 THE DEVICE LEAKED DURING THE PROCEDURE. THE RE-INFUSION WAS COMPLETED WITH NO DELAY AND NO ALLEGATION OF ADVERSE CONSEQUENCES.

    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 10293012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK