BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2398175 · Received January 4, 2012

    Report

    Report Number
    1423500-2012-00266
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    November 27, 2011
    Report Date
    December 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    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 2805 ML DURING THERAPY INITIATED ON (B)(6) 2011 01:13:09, WHICH WAS SUSPECTED TO BE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OF FLUID. REVIEW OF THE EVENT LOG REVEALED THE DRAIN AMOUNT OF 2800ML IN DAY DRAIN 1 WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 01:13:09. THE PATIENT RETAINED FLUID FROM THE PREVIOUS DAY DWELL AND THE DRAIN VOLUME SHOWED UP AS ULTRA FILTRATION IN THE THERAPY LOG. THE ACTUAL DRAIN VOLUME OF 2800ML IS 93% OF THE PRESCRIBED FILL VOLUME (LPFV) OF 3000 ML; THEREFORE, THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 01:13:09. DURING DAY DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 2805ML, INDICATING THE HOME PATIENT (HP) DRAINED 2305ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 3000ML. 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 20 YR