BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2990350 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05306
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR; THE TIDAL TOTAL UF REMOVAL SET TOO LOW. THE LABELING WAS REVIEWED REVEALING THAT THE GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. IN THE GUIDE THEIR IS THE WARNING THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN IIPV SITUATION." THE SUGGESTED SETTING FOR TOTAL UF IS DESCRIBED AS "SEVENTY PERCENT OF THE NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING THE OPTIMUM TOTAL UF. " THE GUIDE ALSO HAS THE NOTE THAT, "IF YOU USE A SOLUTION FOR A TIDAL THERAPY THAT IS DIFFERENT FROM THE SOLUTION USED IN THE PREVIOUS THERAPY, YOU MAY NEED TO ADJUST THE TOTAL UF BASED ON THE CONCENTRATION OF THE NEW SOLUTION." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG OF A HOMECHOICE (HC) THAT OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2012, AT 22:54:31H. AT THIS TIME BAXTER WAS NOT CONTACTED BY THE PATIENT FOR ASSISTANCE. DURING NIGHT DRAIN CYCLE 12, THE PATIENT'S ULTRAFILTRATION READING WAS 2441ML, INDICATING THE HOME PATIENT (HP) DRAINED 1441ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA, AND IS A REPORTABLE MALFUNCTION. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE WHEN THE EVENT OCCURRED. FURTHERMORE, AS THIS EVENT WAS FOUND DURING SERVICE, ANY PATIENT INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93345 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1