BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2202633 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10587
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 3, 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 ASSIGNABLE CAUSE OF THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW WAS DETERMINED TO BE INSUFFICIENT DRAIN, USE ERROR, TIDAL ULTRAFILTRATION (UF) REMOVAL SET TOO LOW. DUE TO THE CRACKED DOOR PISTON, TEMPERATURE VERIFICATION AND ACCURACY CONFIRMATION TESTING WERE UNABLE TO BE PERFORMED. THEREFORE, IT IS UNKNOWN WHETHER THE DEVICE MET SPECIFICATIONS RELATIVE TO THE IIPVS FOUND IN THE RETURNED CUSTOMER DEVICE LOGS.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2011 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 4619 ML + POST THERAPY DRAIN VOLUME 281 ML = 4900 ML, AND THE LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2200 ML, WHICH MET 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 34 YR