BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPUMP DUAL CHANNEL

    MDR report key: 3972966 · Received August 1, 2014

    Report

    Report Number
    0001811755-2014-02753
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT LONGER BE RETURNED AS THE USER FACILITY INDICATED THE FOLLOWING: "CUSTOMER STATES THEY DISCOVERED THEIR LEG HOLDER MACHINE IS WHAT CAUSED THE EVENT NOT THE SMARTPUMP. SHE SAID WHEN THE DOCTOR TIGHTENED THE LEG HOLDER, IT SQUEEZED THE CUFF MAKING IT GO FROM LEG SHAPED TO OVAL AND THUS THE PUMP WAS NOT WORKING CORRECTLY. THEY DO NOT WISH TO RETURN THE PUMP FOR REPAIR OR EVALUATION." THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE THE SMARTPUMP HAD A SMALL LOSS IN PRESSURE, WHICH CAUSED MINIMAL BLEED-THROUGH TO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE SMARTPUMP HAD A SMALL LOSS IN PRESSURE, WHICH CAUSED MINIMAL BLEED-THROUGH TO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450890 SMARTPUMP DUAL CHANNEL TOURNIQUET, PNEUMATIC KCY STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1