BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPUMP DUAL CHANNEL

    MDR report key: 2893961 · Received December 20, 2012

    Report

    Report Number
    1811755-2012-04342
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MFR FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST PRESSURE TWICE DURING A SURGICAL PROCEDURE. THERE WAS BLEED THROUGH INTO THE SURGICAL SITE AND THERE WAS APPROXIMATELY 75-100 CC OF BLOOD LOSS. A RUBBER TOURNIQUET WAS PLACED AROUND THE PATIENTS ANKLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPUMP DUAL CHANNEL KCY STRYKER INSTRUMENTS KALAMAZOO 1217000453

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention