BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3093882 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11397
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE CAUTION: NEGATIVE UF ALARM. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ON HOW TO BYPASS CAUTION: NEGATIVE UF ALARM ON PAGES 15-54 TO 15-56. THE WARNING ON PAGE 15-54 STATES " BYPASSING A CAUTION: NEGATIVE UF ALARM CAN LEAVE FLUID IN THE PERITONEAL CAVITY AND RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION..." THE PAGE CONTINUES WITH NOTES WHICH STATE "DO NOT BYPASS THIS ALARM EXCEPT ON YOUR DIALYSIS CENTER'S ADVICE" AND "FOLLOW THE NEXT STEPS IF YOU ARE SURE IT IS SAFE TO BYPASS A CAUTION: NEGATIVE UF ALARM. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    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 14:04:56. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 2105ML, INDICATING THE HOME PATIENT (HP) DRAINED 2105ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196470 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR