BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3973201 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25041
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AND THE ISSUE WAS IDENTIFIED THROUGH REVIEW OF THE EVENT HISTORY LOGS. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE).  THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE CAUSE WAS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 (NIGHT DRAIN #1) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2014 AT 09:47:53. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THIS MEETS INCREASED INTRA PERITONEAL VOLUME (IIPV) CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450260 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1