BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2436363 · Received February 2, 2012

    Report

    Report Number
    1423500-2012-02221
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    December 6, 2011
    Report Date
    January 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). A REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 1563 ML DURING THERAPY INITIATED ON (B)(6) 2011 01:56:44, WHICH WAS SUSPECTED TO BE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OF FLUID. REVIEW OF THE DEVICE'S EVENT LOG WAS PERFORMED FOR THE THERAPY INITIATED ON (B)(6) 2011 01:56:44. REVIEW OF THE EVENT LOG REVEALED THE CYCLE 5 DRAIN WAS COMPLETED ON (B)(6) 2011 AT 12:15 AND THE USER'S ACTUAL DRAIN VOLUME DURING CYCLE 5 WAS 3117 ML. THE USER HAD A PARTIAL FILL AND THE ACTUAL DRAIN VOLUME OF 3117 ML IS 156% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 2000 ML; THEREFORE, THIS INCIDENT DOES NOT MEET IIPV CRITERIA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WERE IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 01:56:44. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1563ML, INDICATING THE HOME PATIENT (HP) DRAINED 1563ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR