BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3162331 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14961
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 ASSIGNABLE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: (B)(4) HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE. SECTION 10 "OPERATING INSTRUCTIONS - MAKE ADJUSTMENTS" IN 10.2.7 GIVES THE WARNING THAT "TOO LOW AN I-DRAIN ALARM VOLUME CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. SEE TABLE 10-1 ON PAGE 10-11 FOR THE RECOMMENDED STARTING POINTS WHEN DETERMINING YOUR OPTIMUM I-DRAIN ALARM VOLUME." TABLE 10-1 ON PAGE 10-11 GIVES THE RECOMMENDED STARTING POINT FOR I-DRAIN ALARM SETTING AT A MINIMUM OF 70% OF THE LAST FILL VOLUME. 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(S) WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 AT 01:33:59. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1751ML, INDICATING THE HOME PATIENT (HP) DRAINED 1751ML 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
    262634 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1