BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3062482 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09475
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION HAS BEEN COMPLETED. THIS CONDITION 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. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING REVIEW OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 107 ALARM WAS IDENTIFIED. THE ALARM OCCURRED IN NIGHT DRAIN SEVEN AND WAS IDENTIFIED IN THE LOG. THIS MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164240 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1