BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4121579 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33348
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING REVIEW OF THE EVENT HISTORY LOG. A VISUAL INSPECTION WAS PERFORMED. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. THE CAUSE OF THE IIPV EVENT WAS DETERMINED TO BE DUE TO ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. REVIEW OF SERVICE HISTORY REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSED OR CONTRIBUTE TO THE IIPV. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED IN THE LOGS. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 22:36. DURING NIGHT DRAIN CYCLE THREE THE ULTRAFILTRATION (UF) WAS 1545ML, INDICATING THE HOME PATIENT (HP) DRAINED 1545ML MORE THAN THE PRESCRIBED FILL VOLUME OF 2500ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601761 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR