BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4192859 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36909
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    July 4, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS IS AN ANCILLARY SERVICE EVENT. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. A REVIEW OF THE EVENT HISTORY LOG IDENTIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE WAS DETERMINED TO BE USER ERROR, TIDAL TOTAL ULTRAFILTRATION (UF) REMOVAL BEING SET TOO LOW. HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. THE GUIDE WARNS THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY." THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 21:10:14. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 2747ML, INDICATING THE HOME PATIENT DRAINED 2147ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673416 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1