BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3212185 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17775
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE LOGS. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECTED AND A USE ERROR, AS THE INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE STATES IN THE WARNINGS: SETTING THE I-DRAIN ALARM VOLUME TOO LOW OR OFF CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013, DURING NIGHT DRAIN CYCLE ONE. THE PATIENT'S ULTRAFILTRATION READING WAS 1834ML, INDICATING THE HOME PATIENT (HP) DRAINED 1834ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313627 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR