BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3250956 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19944
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 105 (NIGHT DRAIN #5) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURS WHEN A PATIENT HAS DRAINED A VOLUME EQUAL TO 200% OR GREATER THAN THE PATIENT'S FILL VOLUME. THE ALARM OCCURRED ON (B)(6) 2013 AT 22:55:45. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354136 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1