BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3954167 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23988
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    November 13, 2013
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE HIGH DRAIN 109 (NIGHT DRAIN #9) EVENT WAS VERIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED AS NOT ENOUGH EVIDENCE WAS AVAILABLE TO MAKE A DETERMINATION. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE).  THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 109 (NIGHT DRAIN #9) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2013 AT 08:52:48. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430321 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1