BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 1618501 · Received February 8, 2010

    Report

    Report Number
    1618501
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 17, 2010
    Report Date
    February 8, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    MQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE EFFLUENT DRAIN BAG WAS CHANGED ON MACHINE AROUND MIDNIGHT. MACHINE FLIPS HOUR ABOUT 10 MINUTES AFTER ACTUAL TIME. THE OPERATOR WENT BACK TO MACHINE TO GET FLUID REMOVAL VOLUME AND PRESSURE READINGS FROM PREVIOUS HOUR AND NOTED EFFLUENT PRESSURE TO BE ZERO (HAD BEEN 50'S). MONITOR STARTED ALARMING THAT PATIENT'S BLOOD PRESSURE WAS LOW. THERE WERE NO ALARMS ON CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) MACHINE. WHEN CHECKING HISTORY ON MACHINE IT WAS NOTED THAT CURRENT HOUR FLUID REMOVAL WAS ALREADY AT 130 ML IN THE 6-8 MINUTES SINCE THE HOUR HAD FLIPPED, AND STILL NO ALARMS ON MACHINE. THE OPERATOR HIT KEY FOR CHANGE BAG, OPENED SCALE, AND SHUT IT AGAIN. THERAPY WAS RESTARTED AND EFFLUENT PRESSURE BACK TO 40'S. PATIENT'S NEOSYNEPHRINE DRIP INCREASED AND GAVE PATIENT 150 ML OF 0.9 NORMAL SALINE. NO ALARMS OR ISSUES WITH PRESSURES THROUGH THE REST OF SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX HEMODIALYSIS, CONTINUOUS RENAL REPLACE THERAPY MQS GAMBRO RENAL PRODUCTS 107493 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR