BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2252302 · Received September 17, 2011

    Report

    Report Number
    1423500-2011-12357
    Event Type
    Malfunction
    Date Received
    September 17, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 31, 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 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: FALSE EMPTY DETECT AT INITIAL DRAIN AFTER I-DRAIN ALARM VOLUME WAS MET. THE DEVICE WAS IN SPECIFICATION RELATIVE TO IIPV'S FOUND IN THE LOGS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE / PREVENTIVE ACTION AS APPROPRIATE. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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.

    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 CYCLE 1. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 100 ML AND THE DRAIN VOLUME WAS 183 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 PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1