BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 809654 · Received October 27, 2006

    Report

    Report Number
    9616026-2006-00327
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 27, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIVISION
    Product Code
    KPF
    PMA / PMN Number
    k041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO BLOOD LOSS WAS REPORTED. THE DATA FILES HAVE BEEN REVIEWED BY THE MANUFACTURER AND FURTHER QUESTIONS PUT TO THE USER SITE. THE MANUFACTURING SITE WILL CONDUCT FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 1

    THE NURSE REPORTED AN EMPTY PBP BAG AND A FULL EFFLUENT BAG NEARLY AT THE SAME TIME. AS SHE TRIED TO CHANGE THE PBP (PRE BLOOD PUMP) BAG, SHE SAW AN ALARM "EFFLUENT BAG EMPTY" AND IT WAS IMPOSSIBLE FOR HER TO CHANGE INTO THE PBP SCREEN. THE TREATMENT WAS STOPPED. REPORTED MACHINE RUNTIME 2300 (H). NO BLOOD LOSS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS KPF GAMBRO LUNDIA AB, MONITOR DIVISION 6023014700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other