BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPUMP DUAL CHANNEL

    MDR report key: 2758223 · Received September 18, 2012

    Report

    Report Number
    1811755-2012-03548
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE HAD AN ERROR 42. THIS CAUSED THE TOURNIQUET TO LOSE PRESSURE AND A VERY SMALL AMOUNT OF BLEED-THROUGH OCCURRED INTO THE SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AND NO SURGICAL DELAY. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPUMP DUAL CHANNEL KCY STRYKER INSTRUMENTS, INSTRUMENTS DIV. 0901504653

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK