BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 741274 · Received July 21, 2006

    Report

    Report Number
    2087532-2006-00201
    Event Type
    Other
    Date Received
    July 21, 2006
    Date of Event
    June 22, 2006
    Report Date
    June 23, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MACHINE REMOVED TOO MUCH FLUID DURING TREATMENT. THE PT'S TREATMENT WAS SCHEDULED FOR 3.5 HRS. THE PT'S PRE TREATMENT WEIGHT WAS 74.8 KGS. THE TARGET LOSS PROGRAMMED INTO THE PHOENIX HEMODIALYSIS MACHINE WAS 4.2 KGS, WHICH INCLUDED 200 CC NORMAL SALINE TO BE GIVEN DURING RINSEBACK. AT 1 HOUR AND 40 MINUTES INTO THE PT'S TREATMENT THE PT COMPLAINED OF CRAMPING IN THE LEFT LEG. THE STAFF GAVE THE PT 300 CC OF NORMAL SALINE AND DECREASED THE TARGET LOSS ON THE PHOENIX TO 3.8 KGS. THE PT COMPLETED THE 3.5 HOURS OF TREATMENT. THE PT'S POST TREATMENT WEIGHT WAS 70.2 KGS, WHICH WAS A WEIGHT LOSS OF 4.6 KGS. THE PHOENIX HEMODIALYSIS MACHINE RECORDED A FLUID REMOVAL OF 3.78 KGS. WHEN CALCULATING THE NORMAL SALINE GIVEN DURING THE TREATMENT THERE WAS A CALCULATED ERROR OF 1.52 KGS.

    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