BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1812976 · Received August 11, 2010

    Report

    Report Number
    2648666-2010-00347
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 26, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR. A DEVICE HISTORY REVIEW CANNOT BE COMPLETED, AS THE LOT NUMBER WAS NOT PROVIDED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLECTED BLOOD CLOTTED IN THE RESERVOIR. APPROX 100 CC'S OF COLLECTED BLOOD COULD NOT BE RE-INFUSED. THE ACCOUNT HAD A BACK UP TO USE TO COMPLETE THE RE-INFUSION WITH 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK