BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3891411 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20063
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    November 15, 2013
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION WAS COMPLETED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASE INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS CONFIRMED THROUGH 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 COULD NOT BE DETERMINED. 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 105 (NIGHT DRAIN #5) ALARM WAS IDENTIFIED IN THE LOG. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, INDICATING AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE ALARM OCCURRED ON (B)(6) 2013 AT 12:19:38. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367748 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR