BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3031506 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08147
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE NOR MALFUNCTION OF THE DEVICE WAS IDENTIFIED. THE IIPV WAS CONFIRMED BY REVIEW OF THE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE ONE OR MORE CYCLE ADVANCES TO THE NEXT FILL WHEN A SLOW / NO FLOW OCCURRED, ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED. THIS OCCURRED DURING THERAPY IN DRAIN CYCLE 2. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 1584 ML, WHICH INDICATES THAT THE HOME PATIENT (HP) DRAINED 1584 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2600 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS APPROXIMATELY 4184 ML, WHICH MEETS THE IIPV CRITERIA. NO PATIENT INJURY NOR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135231 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE