BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 1822982 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03075
    Event Type
    Death
    Date Received
    September 1, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS EVALUATED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL) AND WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURNED INSTRUMENT TEST EVALUATION (RITE) TESTING. THE DEVICE PASSED THE RITE ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF THE DEVICES ALARM LOG CONFIRMED THE LDV ALARM REPORTED ON (B)(6) 2010. REVIEW OF THE THERAPY AND EVENT LOGS REVEALED THE LAST THERAPY PERFORMED USING THE DEVICE WAS INITIATED (B)(6) 2010 ENDING (B)(6) 2010 AND WAS SUCCESSFULLY COMPLETED. CONTINUED DEVICE LOG REVIEW REVEALED 2 INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED. PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF THE IIPVS FOUND IN THE DEVICE LOGS. THE DEVICE FUNCTIONED AS DESIGNED. REVIEW OF THE DEVICE'S PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE IIPVS FOUND IN THE LOGS OR THE PATIENT EXPIRATION. THE ASSIGNABLE CAUSE OF THE 2 IIPVS FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE THE TIDAL ULTRA FILTRATION (UF) REMOVAL BEING SET TOO LOW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS DEVICE.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 6. THE PATIENT'S DRAIN VOLUME VOLUME WAS 4393ML. THE LARGEST PRESCRIBED FILL VOLUME WAS 2300ML. THIS MEETS IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS IIPV DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE MOST PROBABLE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN. USE ERROR, TIDAL UF REMOVAL SET TOO LOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%?