BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2402386 · Received January 6, 2012

    Report

    Report Number
    1423500-2012-00445
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    May 30, 2011
    Report Date
    December 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP MDR 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. REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 1204 ML DURING THERAPY INITIATED ON (B)(6) 2011 21:57:41, 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) 2011 21:57:41. REVIEW OF THE EVENT LOG REVEALED THE CYCLE 4 DRAIN WAS COMPLETED ON (B)(6) 2011 AT 07:01 AND THE USER'S ACTUAL DRAIN VOLUME DURING CYCLE 4 WAS 3189 ML. THE ACTUAL DRAIN VOLUME OF 3189 ML IS 159% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 2000 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, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 21:57:41. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1204ML, INDICATING THE HOME PATIENT (HP) DRAINED 1204ML 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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1