BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II-(3/16" KIT) PKG/6 WORLD

    MDR report key: 3080020 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00905
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CBC II-(3/16" KIT) PKG/6 WORLD ALLEGEDLY HAD THE DRAIN TUBE DETACH FROM THE RESERVOIR. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE. THE EVENT WAS NOTICED AFTER SURGERY. NO BAGGED OR PRE-DONATED BLOOD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182381 CBC II-(3/16" KIT) PKG/6 WORLD APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12229012

    Patients

    Seq Age Sex Outcome Treatment
    1