BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBCII(NO DRN)PKG/6 W/CAPACITOR

    MDR report key: 2091449 · Received May 4, 2011

    Report

    Report Number
    2648666-2011-00127
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT, AND NO LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THAT A TOURNIQUET WAS APPLIED AT THE WOUND SITE AND THE VACUUM CONTROL DIAL WAS TURNED ON IMMEDIATELY AFTER THE TOURNIQUET WAS REMOVED. THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS DEVICE CONTAINS A NOTE WHICH STATES: IF A TOURNIQUET IS USED, WAIT 15 MINS AFTER THE TOURNIQUET IS RELEASED BEFORE TURNING ON THE BLOOD CONSERVATION SYSTEM. THIS NOTE IS INTENDED TO ASSIST IN PREVENTING CLOTTING IN THE RESERVOIR. THE SALES REP HAS RE-TRAINED THE ACCOUNT ON THE INFO CONTAINED IN THE IFU APPLIED WITH THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLECTED BLOOD CLOTTED IN THE RESERVOIR. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. A BACK UP DEVICE WAS USED AND THE RE-INFUSION WAS SUCCESSFULLY COMPLETED. THE PT ALSO REPORTED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII(NO DRN)PKG/6 W/CAPACITOR CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention