BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4170934 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35839
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. THIS IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE AN INAPPROPRIATE BYPASS OF THE DRAIN PHASE. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ON HOW TO BYPASS THE DRAIN PHASE. 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 EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 09:52:30. DURING NIGHT DRAIN CYCLE NINE, THE PATIENT'S ULTRAFILTRATION READING WAS 379ML, INDICATING THE HOME PATIENT DRAINED 379ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649601 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1