BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 512281 · Received January 15, 2004

    Report

    Report Number
    1423500-2004-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2004
    Date of Event
    December 16, 2003
    Report Date
    December 16, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY TECHNICIAN REPORTED A PT REMOVED MORE ULTRAFILTRATION (UF) THAN INTENDED DURING A TREATMENT ON A SYSTEM 1000 HEMODIALYSIS MACHINE. THE UF INTENDED WAS 0.6 KG BUT THE ACTUAL AMOUNT REMOVED WAS 2 KG. LIMITED INFO IS AVAILABLE REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE CORP. SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN