BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 514213 · Received January 15, 2004

    Report

    Report Number
    1423500-2004-00038
    Event Type
    Other
    Date Received
    January 15, 2004
    Date of Event
    December 22, 2003
    Report Date
    December 22, 2003
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY TECHNICIAN REPORTED THAT A PT REMOVED LESS THAN THE INTENDED AMOUNT OF ULTRAFILTRATION (UF) DURING A TREATMENT ON A SYSTEM 1000 HEMODIALYSIS MACHINE. THERE WERE NO MACHINE ALARMS THAT INDICATED A PROBLEM WITH THE TREATMENT. HOWEVER, THE MACHINE PROVIDED A TRANSMEMBRANE PRESSURE READING THAT WAS LOWER THAN EXPECTED. THIS WAS NOT NOTED UNTIL AFTER THE TREATMENT WAS COMPLETE. THE INTENDED UF WAS 6.1 KG. HOWEVER, THE PT ACTUALLY ENDED THE TREATMENT 0.5 KG HEAVIER THAN THE START OF THE TREATMENT. THIS WAS EXPLAINED BY THE USE OF 0.5 KG OF SALINE RINSE USED DURING THE TREATMENT. THE PT WAS ASYMPTOMATIC AND THERE WAS NO PT INJURY ASSOCIATED WITH THIS INCIDENT. THE PT WAS DIALYZED A SECOND TIME FOR UF REMOVAL ONLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other 1. MEDISYSTEMS BLOODLINES, 2003,| 2. TERUMO EE20, DIALYZER, 2003.