BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3923027 · Received July 9, 2014

    Report

    Report Number
    0001811755-2014-02435
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    CAC
    PMA / PMN Number
    K970714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE USER FACILITY; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE. THE DEVICE WAS DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE THE BLOOD SEEMED TO BE CLOTTING IN THE BAXTER 40/150 MICRON FILTER FOR THE CBC II BLOOD CONSERVATION KIT. AS A RESULT, THE 700 CC OF BLOOD COLLECTED FROM THE PATIENT COULD NOT BE REINFUSED. MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES ARE UNKNOWN. MULTIPLES ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399993 CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC WOUND DRAIN APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12191012

    Patients

    Seq Age Sex Outcome Treatment
    1