BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2120578 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07448
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 10, 2011
    Report Date
    May 19, 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 DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY PAL (PRODUCT ANALYSIS LAB). THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST BUT FAILED THE RITE FUNCTIONAL TEST FOR VOLUMETRIC ACCURACY DURING DRAIN 1. THE DEVICE ALSO FAILED ACCURACY ENCOUNTERED DURING PAL TESTING, UNRELATED TO THE REPORTED ISSUE AND THE ASSIGNABLE CAUSE: IMPROPER INSTALLED PISTON FOAM. THE PISTON FOAM WILL BE SCRAPPED DURING SERVICE. THE ASSIGNABLE CAUSE OF THE RITE VOLUMETRIC ACCURACY TEST FAILURE WAS UNDETERMINED. THE DEVICE WAS DETERMINED NOT TO MEET THE SPECIFICATION REQUIREMENTS. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS UNDETERMINED. A DEVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2011 DURING DRAIN CYCLE 1. THE PATIENT'S ULTRAFILTRATION READING WAS 1589ML, INDICATING THE HOME PATIENT (HP) DRAINED 1589ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR