BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN

    MDR report key: 3063478 · Received April 17, 2013

    Report

    Report Number
    0001811755-2013-00815
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND NO ADDITIONAL QUALITY INVESTIGATION CAN BE PERFORMED. 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/3/16 INCHROUND PVC WOUND DRAIN WAS ALLEGEDLY NOT ABLE TO TRANSFER COLLECTED BLOOD TO THE BLOOD BAG FROM THE RESERVOIR. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE. NO BLOOD INFUSION WAS REQUIRED. THE CBC2 WAS CONTINUED TO BE USED JUST AS A DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164672 CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12179012

    Patients

    Seq Age Sex Outcome Treatment
    1