BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2241856 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11995
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS DETERMINED TO BE INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. DEVICE MET SPECIFICATIONS RELATIVE TO IIPV IN THE LOGS. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION OF THE DEVICE THAT WOULD CONTRIBUTE TO THE IIPV. A REVIEW OF THE DEVICE SERVICE HISTORY FOR THIS PARTICULAR HOMECHOICE REVEALED THE PREVIOUS SWAP WAS UNRELATED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING DRAIN CYCLE 4. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 1456 ML, INDICATING THE HOME PATIENT (HP) DRAINED 1456 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2000 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS APPROXIMATELY 4456 ML, WHICH MEETS THE IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 41 YR