BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2924590 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01592
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    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 OPENED DURING INVESTIGATION OF (B)(4). REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 47678 ML DURING THERAPY INITIATED ON (B)(6) 2012 22:41:38, 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. "REVIEW OF THE EVENT LOG REVEALED THAT THERAPY WAS COMPLETED ON (B)(6) 2012 07:26:21 AFTER THE COMPLETION OF DRAIN 2, AND THERE WAS NO CYCLE 3 IN THIS THERAPY, THEREFORE, THERE WAS NO IIPV EVENT IN CYCLE 3". THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IIPV IS NOT CONFIRMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ASSIGNABLE 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, THREE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS WERE IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 22:41:38. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 47678ML, INDICATING THE HOME PATIENT (HP) DRAINED 47678ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2300ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30809 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR