BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2023895 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03395
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 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 RECEIVED AND EVALUATED. THE DEVICE MET SPECIFICATIONS. VOLUME OF FLUID DRAINED THAT MEETS IIPV CRITERIA FOUND IN THE LOGS ONLY. THE ROOT CAUSE: INSUFFICIENT DRAIN, USE ERROR: TIDAL UF REMOVAL SET TOO LOW. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF IIPV. LABELING WAS REVIEWED FOR USE ERROR(S) AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. 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 RTB-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS IDENTIFIED IN THE PATIENT THERAPY LOG ON (B)(6) 2011 WITH DRAIN VOLUME OF 4497 ML DURING CYCLE 12. THERE HAS BEEN NO PATIENT INJURY OR MEDICAL INTERVENTION 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 64 YR