BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3122064 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13002
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE 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. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED. A REVIEW OF THE DEVICE LOG CONFIRMED THE REPORTED DIFFICULTY OF IIPV-ADULT (HIGH DRAIN VOLUME 101). THE DEVICE PASSED FUNCTIONAL TESTING AND ELECTRICAL TESTING. ALL PRESSURES ON THE DEVICE WERE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. AN INTERNAL INSPECTION WAS PERFORMED AND NO PROBLEMS WERE FOUND. THE ALARM COULD NOT BE DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER HAD A HIGH DRAIN ALARM (AN INDICATOR OF INCREASED INTRAPERITONEAL VOLUME) ON A HOMECHOICE (HC) MACHINE DURING USE; PATIENT CONNECTED IN DRAIN ONE OF ONE. THE ULTRAFILTRATION WAS 4939ML. THE HOME PATIENT (HP) HAD LARGEST PRESCRIBED FILL VOLUME OF 2000 ML AND A PREVIOUS ULTRAFILTRATION OF -500 ML AND DRAINED ONLY 178ML IN THE INITIAL DRAIN. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224398 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR UNKNOWN CASSETTE| DIANEAL SOLUTION