BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3041952 · Received April 9, 2013

    Report

    Report Number
    1416980-2013-08795
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 20, 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
    IT
    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, TIDAL TOTAL ULTRAFILTRATION REMOVAL WAS SET TOO LOW. THE 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." PAGE 9-22 STATES "SEVENTY PERCENT (70%) OF YOUR NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING YOUR OPTIMUM TOTAL UF." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2013 AT 21:49:34. DURING NIGHT DRAIN CYCLE 12, THE PATIENT'S ULTRAFILTRATION READING WAS 1654ML, INDICATING THE HOME PATIENT (HP) DRAINED 904ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. THIS INFORMATION MEETS IIPV CRITERIA. THIS INFORMATION MEETS IIPV CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147561 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1