BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 809640 · Received October 27, 2006

    Report

    Report Number
    9616026-2006-00329
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    September 28, 2006
    Report Date
    September 28, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIVISION
    Product Code
    KPF
    PMA / PMN Number
    k041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 RECEIVED AND REVIEWED. INITIAL INVESTIGATION SUGGESTS THAT THIS IS A CASE OF FLOW-RATE DISCREPANCY. THE MANUFACTURING SITE IS CONDUCTING FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED ON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCREPANCY BETWEEN THE SET FLOW RATE AND THE TRUE FLOW RATE ON THE REPLACEMENT PUMP, WHICH RESULTED IN A WRONG REPLACEMENT WEIGHT LOSS AND A WRONG EFFLUENT WEIGHT. NO BLOOD LOSS REPORTED. REPORTED MACHINE RUNTIME 1946 (H).

    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