BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE

    MDR report key: 2083300 · Received May 4, 2011

    Report

    Report Number
    2083300
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 10, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    FROM PROVIDER REPORT: CONTINUOUS BLOOD LOSS OOZED THROUGHOUT CASE. IT WAS DIFFICULT TO TELL AMOUNT OF EBL (ESTIMATED BLOOD LOSS) BY VISUAL INSPECTION OF FIELD. SURGEONS STATE EBL WAS SIGNIFICANT. SURGEONS WERE SUCTIONING BLOOD "LOOSED" INTO NEPTUNE DEVICE THROUGHOUT CASE. IN MIDDLE OF CASE THE NEPTUNE DEVICE MEASURED 450 ML. INSPECTION OF FLUID CHAMBER = 1800 ML. CLINICAL ENGINEERING EVALUATION: EBL IS ESTIMATED BLOOD LOSS. UNIT WAS TESTED AFTER THE CASE AND CONFIRMED THAT THE VOLUME DISPLAY WAS GROSSLY INACCURATE AT THE LOW END OF THE RANGE. THE NEPTUNE HAS A DIGITAL DISPLAY TO INDICATE THE VOLUME IN THE CHAMBER. THE CHAMBER ALSO HAS GRADUATIONS ON THE SIDE FOR A COARSE MEASUREMENT. ACCORDING TO THE MANUFACTURER'S SPECIFICATION, THE DIGITAL DISPLAY SHOULD BE ACCURATE TO +/- 175ML. WE OBSERVED ERRORS IN EXCESS OF 1000ML ON SEVERAL MACHINES. EBL DURING THE CASE IS A FACTOR IN DECIDING WHETHER THE PATIENT NEEDS ADDITIONAL BLOOD TO MAKE UP FOR LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE WASTE MANAGEMENT SYSTEM FYD STRYKER INSTRUMENTS 700-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR