BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3864007 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18549
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. 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 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 EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 21:44. DURING DRAIN CYCLE ONE THE HOME PATIENT (HP) DRAINED 4318ML WITH A LARGEST PRESCRIBED FILL VOLUME OF 2400ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339142 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR