BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3942889 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23133
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE HIGH DRAIN 101 (NIGHT DRAIN 1) EVENT WAS VERIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED AS NOT ENOUGH EVIDENCE WAS AVAILABLE TO MAKE A DETERMINATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 (NIGHT DRAIN 1) ALARM WAS IDENTIFIED IN THE LOG (INCLUDES ANY STANDARD MODE THERAPY WHERE THE PATIENT DRAIN VOLUME EXCEEDS 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). THE ALARM OCCURRED ON (B)(6) 2014 18:02:31. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419658 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR