BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2040174 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04118
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 13, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE 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 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. ON (B)(4) 2011 IN CYCLE 5 THE USER DRAINED 2405 ML. THE VOLUME WAS GREATER THAN 160% OF THE LARGEST PRESCRIBED FILL VOLUME OF 1500 ML AND MET IIPV CRITERIA. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN. USE ERROR. TIDAL UF REMOVAL SET TOO LOW. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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).

    Description of Event or Problem · 1

    FIVE INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 2 OF 5. THE IIPV OCCURRED ON (B)(6) 2011 DURING DRAIN CYCLE 5. THE PROGRAMMED FILL VOLUME WAS 1500ML. THE DRAIN VOLUME WAS 2405ML. THIS VOLUME MEETS BAXTER'S 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR