BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1990257 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01953
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 23, 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 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). BAXTER CONTACTED THE NURSE TO NOTIFY OF THIS INCIDENT OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS FOUND DURING THE DEVICE LOG REVIEW. THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE IIPV EVENT. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENTAGE SETTING TOO LOW. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. A DEVICE HISTORY WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE IIPV IN THE LOGS DURING THE MANUFACTURE OF THE LOT OR SERIAL NUMBER. 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

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2011 DURING DRAIN CYCLE 16. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 46 ML, INDICATING THE HOME PATIENT (HP) DRAINED 46 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 140 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS 186 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, DOMESTIC 120V SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO