BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2512702 · Received April 2, 2012

    Report

    Report Number
    1423500-2012-07670
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 2030 ML DURING THERAPY INITIATED ON (B)(6) 2012 20:01:51, WHICH WAS SUSPECTED TO BE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OF FLUID. AN IIPV IS ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, AS DEFINED IN THE (B)(4) CLINICAL HAZARDS LIST. A REVIEW OF THE DEVICE'S EVENT LOG WAS PERFORMED FOR THE THERAPY INITIATED ON (B)(6) 2012 20:01:51. REVIEW OF THE EVENT LOG REVEALED THE CYCLE 2 DRAIN WAS COMPLETED ON (B)(6) 2012 AT 01:18 AND THE USER?S ACTUAL DRAIN VOLUME DURING CYCLE 2 WAS 3030 ML. THE USER POWERED OFF DURING DRAIN 3 AND THE ULTRA FILTRATION (UF) IN DRAIN CYCLE 3 WAS COMBINED WITH THE UF IN DRAIN CYCLE 2 GIVING UF OF 2030ML. ALSO, CYCLE 3 DRAIN WAS COMPLETED ON (B)(6) 2012 AT 05:12 AND THE USER?S ACTUAL DRAIN VOLUME DURING CYCLE 3 WAS 3766 ML. THE ACTUAL DRAIN VOLUME OF 3030 ML IN CYCLE 2 IS 121% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 2500 ML AND THE ACTUAL DRAIN VOLUME OF 3766 ML IN CYCLE 3 IS 150% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 2500 ML THEREFORE, THESE INCIDENTS DO NOT MEET IIPV CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 20:01:51. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 2030ML, INDICATING THE HOME PATIENT (HP) DRAINED 2030ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR