BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3974578 · Received August 3, 2014

    Report

    Report Number
    1416980-2014-25156
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    March 28, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED FOR THE REPORTED EVENT. A REVIEW OF THE EVENT HISTORY LOG VERIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THAT ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE).  THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. 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 23:22:00. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1190ML, INDICATING THE HOME PATIENT (HP) DRAINED 1190ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452564 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR