BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2231284 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11554
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - TAMPA
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF BURNT ODOR FROM HOMECHOICE (HC) DEVICE WAS NEITHER CONFIRMED NOR REPRODUCED DURING THE EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. THE DEVICE FUNCTIONED PROPERLY WITH NO ISSUES ENCOUNTERED, AND NO SMOKE OR BURNS WERE DISCOVERED. A SERVICE HISTORY REVIEW REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. A ROOT CAUSE COULD NOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOME CHOICE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) TO REPORT THAT HE SMELLED A BURNT ODOR FROM THE CASSETTE DURING THERAPY ON THE HOMECHOICE (HC) CYCLER. THE PATIENT WANTED TO SWAP THE HC DEVICE. NO CLINICAL IMPACT ON THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - TAMPA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CASSETTE