BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082110 · Received July 25, 2008

    Report

    Report Number
    1423500-2008-00686
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 4, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE DID NOT WISH TO RETURN THE HOMECHOICE MACHINE FOR EVAL. NO ADDITIONAL INFO WAS AVAILABLE REGARDING THE INCIDENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A DRAIN VOLUME ON THE HOMECHOICE (HC) AUTOMATED PERITONEAL DIALYSIS (APD) MACHINE DURING INITIAL DRAIN CYCLE. THE DRAIN VOLUME WAS 765ML WITH THE LAST FILL VOLUME WAS 200ML. THE INITIAL DRAIN ALARM WAS SET AT 1000ML. THE TSR EXPLAINED ALARM TO THE HP. THE TSR ASSISTED HP TO REVIEW HC PROGRAMMING AND HC SET UP. THE PT SAID SHE DID NOT HAVE ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THIS INCIDENT. THE PT SAID SHE MAY HAVE BYPASSED A CYCLE. PER THE NURSE, 200ML WAS SETTLED AS THE LAST FILL VOLUME AND THE INITIAL DRAIN ALARM SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR