BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 970462 · Received January 5, 2007

    Report

    Report Number
    2087532-2007-00016
    Event Type
    Other
    Date Received
    January 5, 2007
    Date of Event
    December 7, 2006
    Report Date
    December 8, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIV.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER KEPT GETTING AN INCORRECT DIALYSATE WEIGHT ALARM AND INCORRECT EFFLUENT WEIGHT ALARM. THEY DID ALL CLINICAL TROUBLESHOOTING OVER THE PHONE, CHANGED BAGS BUT THEY COULD NOT GET THE SCALE TO CALIBRATE CORRECTLY. PT WAS ON MACHINE BUT THE PT HAD NO ISSUES. THEY MOVED THE PT TO AN OLDER PRISMA MACHINE TO CONTINUE THE TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other