BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 725893 · Received May 10, 2006

    Report

    Report Number
    9616240-2006-00335
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 10, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    PMA / PMN Number
    k001156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, NO PATIENT'S INFORMATION WAS PROVIDED. A CLINICAL INVESTIGATION REMAINS ONGOING. GAMBRO TECHNICIAN FOUND A CONDUCTIVITY OF AROUND17 MS/CM FOR A SET VALUE OF ABOUT 14 MS/CM. CUSTOMER ADMITTED THAT THE FACILITY TECHNICIAN SHOULD HAVE TAKEN A LABORATORY SAMPLE BUT THIS DID NOT HAPPEN. PHONEIX OPERATOR'S MANUAL, SECTION 5.4 - "SPECIAL PROCEDURES", WARNS: "IT IS THE REPONSIBILITY OF THE USER TO DETERMINE THE CORRESPONDENCE BETWEEN THE DIALYSATE CONDUCTIVE, DISPLAYED BY THE MACHINE, AND THE DIALYSATE SOLUTE CONTENT, VERIFIED BY CLINICAL LABORATORY RESULTS, FOR EACH DIALYSATE CONCENTRATE USED OFR DIALYSIS TREATMENT. THIS CAN BE DONE BY TAKING DIALYSATE SAMPLES AT DIFFERENT CONDUCTIVITY VALUES (E.G.13,14,15 MD/CM) AND SENDING THEM TO A LABORATORY FOR ANALYSIS." 510(K)# IS K001156

    Description of Event or Problem · 1

    THE CUSTOMER SUSPECTED THE MACHINE WAS NOT CORRECTLY CALIBRATED FOR CONDUCTIVITY DURING A CHECK OF THE PATIENT LABORATORY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT FII GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other