BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 720957 · Received May 26, 2006

    Report

    Report Number
    9616026-2006-00207
    Event Type
    Malfunction
    Date Received
    May 26, 2006
    Date of Event
    May 3, 2006
    Report Date
    May 4, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIV
    Product Code
    FII
    PMA / PMN Number
    k041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT WITH SPEEDING PRE BLOOD PUMP. THE NURSE CHANGED PBP-BAG AND WHEN SHE STARTED THE MACHINE, ALARMS FOR INCORRECT WEIGHT CHANGE AT THE PBP OCCURRED TWO TIMES. THE NURSE DISCOVERED THAT SHE HAD FORGOTTEN TO OPEN THE CLAMP AT THE PBP-LINE AND WHEN SHE OPENED THE CLAMP, THE PBP PUMP SPEEDED UP RAPIDLY. CONSEQUENTLY, PBP-FLUID WAS PUMPED INTO THE PATIENT. IT WAS VISIBLE AS THE RED EXTENSION LINE AT THE CATHETER TURNED FROM BLOOD INTO CLEAR WATER. THE MACHINE WAS STOPPED ON THE MAIN SWITCH AND THE PATIENT WAS MOVED TO ANOTHER MACHINE THAT WAS AVAILABLE APPROXIMATELY 1 HOUR LATER. REPORTED BLOOD LOSS VOLUME WAS 150ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS FII GAMBRO LUNDIA AB, MONITOR DIV 107493 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other