BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AKSYS

    MDR report key: 501892 · Received December 3, 2003

    Report

    Report Number
    MW1030467
    Event Type
    Malfunction
    Date Received
    December 3, 2003
    Date of Event
    October 29, 2003
    Report Date
    November 20, 2003
    Manufacturer
    AKSYS LTD.
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AKSYS HEMODIALYSIS MACHINE HAD "DIALYSATE LEAK". PT HAD SHORTENED TREATMENT AND PT MISSED TREATMENT THE NEXT DAY WHILE MACHINE WAS BEING REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKSYS PERSONAL HEMODIALYSIS MACHINE KPF AKSYS LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other