BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3191456 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16498
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING REVIEW OF THE EVENT HISTORY LOG, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THE CAUSE OF THE REPORTED ISSUE WAS FALSE EMPTY DETECT AND USE ERROR, CLINICIAN SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. A REVIEW OF THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE LABELING WAS PERFORMED. SECTION ON TREATMENT - OVERFILL / IIPV WAS REVIEWED. THE WARNING WITHIN THE GUIDE STATES: "THE NEGATIVE UF LIMIT SHOULD NOT BE RAISED ABOVE 50% AND THE MINIMUM DRAIN VOLUME % SHOULD NOT BE LOWERED BELOW 85% (THE DEFAULT VALUES)." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT 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 WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 AT 20:57:19. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1105ML, INDICATING THE HOME PATIENT (HP) DRAINED 1105ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289998 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1