BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 6732423 · Received July 19, 2017

    Report

    Report Number
    MW5071136
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    July 18, 2017
    Report Date
    July 19, 2017
    Manufacturer
    BAXTER HEALTHCARE (RENAL DIV)
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROX 2-3 MONTHS AGO, OUR ESRD PTS USING BAXTER AMIA 2.0 MACHINE, BEGAN EXPERIENCING MULTIPLE ALARMS THROUGHOUT THEIR PD TREATMENT. THE PTS HAVE BEEN INSTRUCTED TO CONTACT TECH SUPPORT FOR ASSISTANCE. IN DOING SO, BAXTER HAS BEEN SLOW TO RESPOND TO WHAT WE FEEL ARE LOT SPECIFIC ISSUES RELATED TO THE CARTRIDGE/TUBING. THE ALARMS HAVE BECOME SO BURDENSOME, THAT PTS ARE CUTTING TREATMENT SHORT AND/OR SKIPPING TREATMENT ENTIRELY. ADDITIONALLY, TECH SUPPORT HAS INSTRUCTED SOME PTS TO DISCONTINUE TREATMENT FOR THE NIGHT AS THEY COULD NOT CORRECT THE ALARM. WHEN TECH SUPPORT TROUBLESHOOTS THE PROBLEM, THEY HAVE SENT OUT ENTIRELY NEW MACHINES TO SOME PTS AND PER THE PT, SOME ALARMS HAVE DECREASED WITH NEW MACHINES, OTHERS FOUND NO IMPROVEMENT. THE PD STAFF HAVE BEEN TRACKING WHAT WE FEEL AS AFFECTED LOT NUMBERS OF THE DISPOSABLE CARTRIDGE/LINES (REF (B)(4)). THE AFFECTED LOTS ARE LISTED: H16K03079, H16J03014, H16J30058, H16I30091, H16J20109, H16J26072, H16J09078, H16J14011, AND H16H09063.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505204 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16K03079
    505205 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J14011
    505206 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J03014
    505207 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J30058
    505208 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J20109
    505209 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J26072
    505210 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16J09078
    505211 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16H09063
    505212 BAXTER AMIA HOME DIALYSIS MACHINE FKX BAXTER HEALTHCARE (RENAL DIV) AMIA 2.0 AUTOMATED PD SYSTEM H16I30091

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R