BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3973628 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25108
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE HIGH DRAIN 105 (NIGHT DRAIN #5) EVENT WAS VERIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED AS NOT ENOUGH EVIDENCE WAS AVAILABLE TO MAKE A DETERMINATION. 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 105 (NIGHT DRAIN #5) ALARM WAS IDENTIFIED IN THE LOG (INCLUDES ANY STANDARD MODE THERAPY WHERE THE PATIENT DRAIN VOLUME EXCEEDS 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). THE ALARM OCCURRED ON (B)(6) 2014 06:35:13.:17:54. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449813 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1