BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 726091 · Received June 8, 2006

    Report

    Report Number
    9616026-2006-00227
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 9, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIVISION
    Product Code
    MQS
    PMA / PMN Number
    k041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THREE INCIDENTS WITH THIS MACHINE. (SEE MDR 9616026-2006-00211 AND 00226). A GAMBRO TECHNICIAN EVALUATED THE MACHINE AND CONCLUDED THAT THE HIGH PRESSURE AND GENERAL SYSTEM FAILURES WERE DUE TO A MALFUNCTIONING CLAMP DURING THE AUTO TEST. FURTHER INVESTIGATION IS BEING CONDUCTED BY THE MANUFACTURER. NO PT INJURY NOR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT IS AWARE OF THIS MACHINE MALFUNCTION (GENERAL SYSTEM FAILURE) AND IS WORKING ON CORRECTIONS. 510(K)# IS K041005.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT WITH HIGH PRESSURE PROBLEMS AND MACHINE 'GENERAL SYSTEM FAILURE' ERROR CODES DURING TREATMENT. MACHINE RUNTIME 3141 HOURS. BLOOD LOSS VOLUME UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other