BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3022886 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07377
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT 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, NO IIPV OCCURRED. THE PATIENT WAS FILLED WITH A FILL VOLUME OF 250ML, SUBSEQUENTLY, THE FILL VOLUME WAS CHANGED SEVERAL TIMES DURING CYCLE 3, WITH A FINAL VALUE OF 100ML. THE DRAIN VOLUME OF 217 WAS GREATER THAN 200% OF THE FINAL FILL VOLUME VALUE OF 100ML, HOWEVER, IT IS LESS THAN 160% OF THE ORIGINAL FILL VOLUME VALUE OF 250ML, NOT MEETING IIPV CRITERIA. IIPV WAS UNCONFIRMED. THE CAUSE WAS UNDETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN ERROR 103 (NIGHT DRAIN #3) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2013, 08:15:25. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127167 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR