BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD SYSTEM

    MDR report key: 3943393 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23182
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    December 29, 2013
    Report Date
    June 24, 2014
    Manufacturer
    DEKA RESEARCH DEVELOPMENT
    Product Code
    FKX
    PMA / PMN Number
    K124018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE AMIA DEVICE WAS EVALUATED. A VISUAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. THE FUNCTIONAL RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING WAS CONDUCTED, ALONG WITH ELECTRICAL TESTING AND NO FAILURES WERE IDENTIFIED RELATED TO THE REPORTED EVENT. THE DEVICE MET PRODUCT SPECIFICATION RELATED TO THE REPORTED ISSUE. THE EVENT HISTORY LOG REVIEW WAS PERFORMED AND IDENTIFIED AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. DURING THE NIGHT CYCLE 3, THE PATIENT'S DRAIN VOLUME WAS 2798.6ML, INDICATING THE HOME PATIENT (HP) DRAINED A VOLUME 128.669% ABOVE THEIR MAXIMUM PROGRAMMED FILL VOLUME (MPV) OF 2175ML. THE IIPV WAS DETERMINED TO BE CAUSED BY THE ESTIMATED NIGHT ULTRA FILTRATION (UF) BEING SET TOO LOW. THE UF WAS SET TOO LOW AT 300ML WHILE DEVICE DRAINED 2798.6ML. THE PROGRAMMED CYCLE FILL VOLUME WAS 1500ML AND THE INITIAL DRAIN VOLUME SETTING WAS 0ML. PROPER INSTRUCTIONS ARE ADDRESSED IN THE ¿AMIA AUTOMATED PD SYSTEM CLINICIAN GUIDE¿. THE GUIDE EXPLAINS THE ESTIMATED NIGHT UF SETTINGS, PROVIDES TREATMENT AND PROGRAMMING ANSWERS ON THIS SETTING AND HAS WARNINGS REGARDING SETTING IT TOO LOW. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SUBSEQUENT TO THIS IIPV EVENT, THE PRESCRIPTION WAS ADJUSTED TO INCREASE THE ESTIMATED UF TO 400ML AND THERE WERE NO IIPV EVENTS REPORTED AT THIS UF SETTING. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED AMIA DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED, WHICH OCCURRED ON (B)(6) 2013. DURING NIGHT CYCLE 3, THE PATIENT'S DRAIN VOLUME WAS 2798.6ML, INDICATING THE HOME PATIENT (HP) DRAINED A VOLUME 128.669% ABOVE THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2175ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422956 AMIA AUTOMATED PD SYSTEM SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX DEKA RESEARCH DEVELOPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR