BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 726109 · Received June 8, 2006

    Report

    Report Number
    9616026-2006-00213
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 8, 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
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE DOWNLOADED MACHINE DATA FILES AND ADDITIONAL INFORMATION RELATING TO THIS INCIDENT. FURTHER INVESTIGATION IS BEING CONDUCTED BY THE MANUFACTURER. NO PT INJURY NOR MEDICAL INTERVENTION WAS REPORTED. 510(K)# IS K041005.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT DURING TREATMENT/RUN WHERE THEY CHANGED THE SETFLOW FOR REPLACEMENT FROM 750ML/H TO 1000ML/H, BUT THE STATUS SCREEN STILL DISPLAYS 750ML/H. NO MACHINE ERROR CODES OR BLOOD LOSS REPORTED.

    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