BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 678585 · Received February 23, 2006

    Report

    Report Number
    9616026-2006-00034
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    October 24, 2005
    Report Date
    October 28, 2005
    Manufacturer
    GAMBRO LUNDIA AB/MONITOR DIVISION
    Product Code
    MQS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A CVVHDF THERAPY THE PRISMAFLEX MACHINE WAS USED WITH AN ECMO MACHINE (HEART LUNG MACHINE). FLOW RATE: BLOOD FLOW: 50 ML/MIN, PBP 100 ML/MIN, DIALYSATE: 0 ML/H REPLACEMENT: 100 ML/H, PT FLUID REMOVAL: 40ML/H, THE NURSES OBSERVED 4 VERY FAST RUNNING FLUID PUMPS 10 MINUTES AFTER THEY HAD CHANGED THE REPLACEMENT AND PBP BAG. THE ECMO MACHINE PRODUCED AN AIR ALARM, THE PRISMAFLEX SLAVE PUMPS KEPT RUNNING AND THE ACCESS - AND PBP LINE WAS FILLED WITH AIR. AFTER CHANGING THE REPLACEMENT FLUID BAG AND THE PBP BAG, THE NURSES OBSERVED 4 FAST RUNNING FLUID PUMPS. THE ECMO MACHINE PRODUCED AN AIR ALARM WHILE THE PRISMAFLEX FLUID PUMPS KET RUNNING AND THE ACCESS AND PBP LINES FILLED WITH AIR. THE NURSES STOPPED THE TREATMENT AND THE DECISION WAS MADE TO CHANGE THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS MQS GAMBRO LUNDIA AB/MONITOR DIVISION 107493 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DAY Other