BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC

    MDR report key: 1935139 · Received December 6, 2010

    Report

    Report Number
    2648666-2010-00470
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 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 MANUFACTURER FOR INVESTIGATION. 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 THE DEVICE STOPPED WORKING AFTER COLLECTING AN UNKNOWN AMOUNT OF BLOOD AND Y-CONNECTOR CAME OFF. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. THERE WAS NO EXPOSURE DUE TO THE Y-CONNECTOR FALLING OFF. THE SURGEON USED A BACK UP DEVICE TO CONTINUE WITH THE COLLECTION AND RE-INFUSION. THERE WERE NO 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 10174012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK