BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3173382 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15587
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR 2367 (RESUME ERROR, CRITICAL ERROR FOUND) ALARM ON A HOMECHOICE (HC) MACHINE DURING USE. THE HP HAD AN UNKNOWN ALARM, CYCLED THE POWER ON THE HC, AND THE SYSTEM ERROR 2367 OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG AND COULD NOT FIND A PRECEDING ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273163 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE