BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3140671 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13958
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    June 11, 2012
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: (B)(4) HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE. SECTION 9 "OPERATING INSTRUCTIONS - CHANGE PROGRAM" STATES THIS WARNING IN TABLE 9-7 ON PAGE 9-21 "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. IIPV COULD RESULT IN A FEELING OF ABDOMINAL DISCOMFORT, SERIOUS INJURY, OR DEATH. SEE PAGE 18-58 FOR IIPV SYMPTOMS OR IF IIPV IS SUSPECTED. ADDITIONAL CARE SHOULD BE TAKEN TO MONITOR FOR IIPV SYMPTOMS FOR THOSE PATIENTS NOT ABLE TO COMMUNICATE ESSENTIAL INFORMATION TO THEIR CAREGIVER DURING TREATMENT." PAGE 9-22 STATES "SEVENTY PERCENT (70%) OF YOUR NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING YOUR OPTIMUM TOTAL UF. FOR HELP IN CONVERTING 70% OF YOUR EXPECTED TOTAL THERAPY UF INTO A VALUE THAT CAN BE PROGRAMMED AS YOUR TOTAL UF FOR YOUR TIDAL THERAPY, SEE 19.17, DETERMINING TIDAL TOTAL UF AND LAST MANUAL DRAIN UF TARGET VOLUME SETTINGS, ON PAGE 19-18." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 AT 08:07:22. DURING NIGHT DRAIN CYCLE NINE, THE PATIENT'S ULTRAFILTRATION READING WAS 1778ML, INDICATING THE HOME PATIENT (HP) DRAINED 1278ML 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
    241507 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1