BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3233516 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18862
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR WITH THE INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE STATES IN THE WARNING: "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 INTRA-PERITONEAL VOLUME (IIPV) SITUATION." A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED, WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2013 AT 22:41:11. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1479ML, INDICATING THE HOME PATIENT (HP) DRAINED 1479ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1700ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333741 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1