BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3173489 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15603
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, DOCUMENT NUMBER 07-19-63-293 JULY 28, 2010. SECTION 9 "OPERATING INSTRUCTIONS - MAKE ADJUSTMENTS? 9.2.7 I-DRAIN ALARM ON PAGE 9-9 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. IIPV COULD RESULT IN A FEELING OF ABDOMINAL DISCOMFORT, SERIOUS INJURY, OR DEATH. SEE TABLE 9-1 ON PAGE 9-10 FOR THE RECOMMENDED STARTING POINTS WHEN DETERMINING YOUR OPTIMAL I-DRAIN ALARM VOLUME." AND TABLE 9-1 ON PAGE 9-10 GIVES THE RECOMMENDED STARTING POINT FOR I-DRAIN ALARM SETTING AS 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 WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 03:02:15. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1213ML, INDICATING THE HOME PATIENT (HP) DRAINED 1213ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273548 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR