BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802902 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14996
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    August 20, 2013
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 ALARM WAS IDENTIFIED IN AN EVENT HISTORY LOG REVIEW. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE CAUSE OF THE HIGH DRAIN ALARM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED AS A HIGH DRAIN ERROR 101 (NIGHT DRAIN CYCLE ONE) ALARM. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE ALARM OCCURRED ON (B)(6) 2013 11:22:34. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280525 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR