BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1062596 · Received June 17, 2008

    Report

    Report Number
    1423500-2008-00495
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED. FOLLOW-UP IS NOT POSSIBLE.

    Description of Event or Problem · 1

    ON 21 MAY 2008, BAXTER RECEIVED A REPORT OF A SYSTEM ERROR 2240 ALARM AND THE PATIENT DEVELOPED PERITONITIS. BAXTER HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE DATE THE PERITONITIS WAS DIAGNOSED AS WELL AS CULTURE RESULTS AND TREATMENT, BUT WAS UNSUCCESSFUL AT OBTAINING ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 1.5% LO/CAL UB 2L/2L DIANEAL| 1.5% LO/CAL 6L DIANEAL| 4.25% LO/CAL UB 2L/2L DIANEAL| 2.5% LO/CAL UB 2L/2L DIANEAL| 4.25% LO/CAL 6L DIANEAL| 2.5% LO/CAL 6L DIANEAL