BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2140972 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08378
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 7, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE CAUSE OF THE PEDIATRIC IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; CLINICIAN INAPPROPRIATELY SET CAUTION: NEGATIVE UF LIMIT (NEGATIVE UF ALARM) TOO HIGH (AT 60%). 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. 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. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4).THE EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AN INSTANCE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING A REVIEW OF THE RETURNED HOMECHOICE (HC) PATIENT EVENT LOG. ON (B)(6) 2011, THE ULTRAFILTRATION (UF) VOLUME OF 153 MILLILITERS (ML) OCCURRED DURING CYCLE 5. THIS MEETS OVERFILL CRITERIA. NO PATIENT SYMPTOM, INJURY, OR MEDICAL INTERVENTION WAS REPORTED BY THE CUSTOMER.

    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 17 MO