BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3142064 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14038
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    November 26, 2012
    Report Date
    May 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE CAUSE WAS USE ERROR, INAPPROPRIATE BYPASS OF THE DRAIN, NOT INCLUDING I-DRAIN. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE DESCRIBES THE PROCEDURE FOR BYPASSING A LOW DRAIN VOLUME ALARM. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE MACHINE, THREE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT(S) WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 AT 18:06:07. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 2911ML, INDICATING THE HOME PATIENT (HP) DRAINED 2911ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244009 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1