BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3132933 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13557
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE AN UNEXPECTED HIGH ULTRA-FILTRATION (UF) FOR THIS THERAPY COMPARED TO OTHER THERAPIES. 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) 2013 00:11:24. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 27760ML, INDICATING THE HOME PATIENT (HP) DRAINED 27760ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. UPON FURTHER INVESTIGATION, THE UF READING FROM DRAIN CYCLE FIVE WAS ADDED INTO THE UF READING FOR DRAIN CYCLE FOUR DUE TO THE PATIENT ENDING THERAPY BEFORE THE DRAIN WAS COMPLETED. THE DRAIN VOLUME OF DRAIN CYCLE FOUR WAS 2042 ML, WHICH DOES NOT MEET IIPV CRITERIA. HOWEVER, THE PATIENT VOLUME WENT FROM 1998 ML AT THE BEGINNING OF DRAIN CYCLE FIVE TO -27708 ML, INDICATING A DRAIN OF 29706 ML. THIS DRAIN DOES MEET IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236685 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1