BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2342151 · Received November 18, 2011

    Report

    Report Number
    1423500-2011-15227
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    August 2, 2011
    Report Date
    October 28, 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). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. A REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD ULTRAFILTRATION READING OF 2192ML DURING THE THERAPY INITIATED ON (B)(4) 2011 21:15:38 DURING NIGHT DRAIN CYCLE 8, 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 1154817 CLINICAL HAZARDS LIST. A REVIEW OF THE DEVICE'S EVENT LOG WAS PERFORMED FOR THE THERAPY INITIATED (B)(4) 2011 21:15:38. REVIEW OF THE EVENT LOG REVEALED THE CYCLE 8 DRAIN WAS COMPLETED ON (B)(4) 2011 AT 06:05 AND THE USER'S ACTUAL DRAIN VOLUME DURING CYCLE 8 WAS 2467 ML. THE ACTUAL DRAIN VOLUME OF 2467 ML IS 137% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 1800 ML; THEREFORE, THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    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, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 21:15:38. DURING NIGHT DRAIN CYCLE 8, THE PATIENT'S ULTRAFILTRATION READING WAS 2192ML, INDICATING THE HOME PATIENT (HP) DRAINED 2192ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. 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 74 YR