BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2050006 · Received March 14, 2011

    Report

    Report Number
    2648666-2011-00070
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. NO LOT NUMBER WAS RECORDED OR REPORTED TO THE MFR, SO THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. IF FURTHER INFO IS PROVIDED, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAIN LEVER DETACHED FROM THE RESERVOIR AFTER THE DEVICE COLLECTED 400 MLS OF BLOOD. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. THE ACCOUNT HAD A BACK UP DEVICE ON HAND TO CONTINUE WITH THE COLLECTION AND RE-INFUSION. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONVERSATION KIT W/1/8 INCH ROUND PVC AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK