BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1902032 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05917
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 29, 2010
    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). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE LEFT A VOICEMAIL FOR THE PATIENT'S NURSE REGARDING THE IIPV AND RELEVANT INFORMATION (DATE, VOLUME AND CAUSE, ETC.). DEVICE EVALUATION: THE HOMECHOICE WAS EVALUATED BY THE PRODUCT ANALYSIS LAB. THE HOMECHOICE PASSED BOTH THE RETURNED INSTRUMENT TEST/EVALUATION FUNCTIONAL AND ELECTRICAL TESTS. THE ASSIGNABLE CAUSE FOR THE REPORTED CONDITION OF AN IIPV WAS DETERMINED TO BE AN INSUFFICIENT DRAIN (ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN A SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD). REVIEW OF THE SERVICE HISTORY REVEALS THE HOMECHOICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM BAXTER. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    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) 2010, THE DRAIN VOLUME WAS 4538ML DURING CYCLE 4. THIS EVENT MEETS THE CRITERIA FOR OVERFILL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR