BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 3212820 · Received July 2, 2013

    Report

    Report Number
    MW5030795
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP USED FOR 1 PT MOST OF DAY WITH HYDRATION BEFORE AND AFTER CHEMO. PUMP WAS PROGRAMMED FOR RATE OF 600 CC/HR. INFUSION WAS COMPLETED BUT PUMP CONTINUED TO RUN EVEN WITH TRYING THE STOP/START BUTTON, OFF/ON BUTTON AND UNPLUGGING MACHINE. DOOR WAS OPENED AND TUBING REMOVED - NO ALARMS ACTIVATED AND MACHINE CONTINUED THE PUMPING MODE. SEVERAL PEOPLE ATTEMPTED TO STOP MACHINE WITHOUT SUCCESS AND IT WAS STILL RUNNING, UNPLUGGED WHEN WE LEFT WORK THAT EVENING. NO LONGER WAS RUNNING UPON RETURN IN AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301920 Z-800 INFUSION PUMP Z-800 INFUSION PUMP FRN ZYNO MEDICAL LLC Z 800

    Patients

    Seq Age Sex Outcome Treatment
    1