BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3072843 · Received April 23, 2013

    Report

    Report Number
    0001811755-2013-00871
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND NO ADDITIONAL QUALITY INVESTIGATION CAN BE PERFORMED. (B)(4): THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND NO ADDITIONAL QUALITY INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC DRAIN WAS ALLEGEDLY NOT DROPPING BLOOD INTO THE BLOOD BAG. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE CONSEQUENCES WERE ASSOCIATED WITH THE DEVICE. CUSTOMER STATES THE PATIENT WAS REINFUSED WITH THEIR OWN BLOOD AFTER NURSES "MILKED" THE BLOOD THROUGH THE TUBING. IT WAS REPORTED THAT NO BLOOD WAS DISCARDED AND NO ADDITIONAL BLOOD WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174236 CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC DRAIN APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12167012

    Patients

    Seq Age Sex Outcome Treatment
    1