BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 1047420 · Received May 16, 2008

    Report

    Report Number
    2937457-2008-00005
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 17, 2008
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): REMOVED TOO MUCH FLUID, FAILED ONLINE PRESSURE HOLDING TESTS. DIASAFE PLUS FILTER. THIS IS A COMPONENT OF THE HEMODIALYSIS MACHINE WITH A SEPARATE 510K (K944767). (B) (4).

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT THE MACHINE REMOVED 3 KG. TOO MUCH FLUID DURING A HEMODIALYSIS TREATMENT. FLUID REMOVAL WAS SET AT 20 ML/HR. FOR 4 HRS. THE MACHINE PASSED THE SELF TESTS AND THE PRESSURE HOLDING TEST PRIOR TO STARTING THE TREATMENT. ONLINE PRESSURE HOLDING TEST FAILED TWICE DURING TREATMENT BUT TREATMENT WAS CONTINUED. THE PT C/O HEADACHE AND WAS SLIGHTLY HYPOTENSIVE POST TREATMENT AND WAS GIVEN 1 LITER OF SALINE. THE NURSE NOTICED A PUDDLE OF WATER UNDERNEATH THE MACHINE AS SHE WAS MOVING IT. UPON INVESTIGATION, A CRACK WAS FOUND IN THE DIASAFE PLUS FILTER. THE FILTER WAS REPLACED AND THE MACHINE IS BACK IN SVC WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE-NORTH AMERICA 2008K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR