BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3850033 · Received June 4, 2014

    Report

    Report Number
    1416980-2014-17955
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES VISUAL INSPECTION, FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE PROVIDES A WARNING "IF YOU SET THE MINIMUM DRAIN VOLUME PERCENT TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION.¿ A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014, 22:41:13. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 2628ML, INDICATING THE HOME PATIENT (HP) DRAINED 2628ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2800ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325902 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR