BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1822893 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03067
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 11, 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). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TESTS PERFORMED BY THE PRODUCT ANALYSIS LAB (PAL) BUT FAILED THE RITE FUNCTIONAL TESTS DUE TO AN UNRELATED ALARM. THE DEVICE PASSED ALL TESTING PERTAINING TO TEMPERATURE AND VOLUMETRIC ACCURACY AND WAS FOUND TO MEET FUNCTIONAL SPECIFICATIONS RELATIVE TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED VIA DEVICE LOG REVIEW. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN; INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED TOO LOW (0ML). A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV ISSUE. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO IIPV. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE ULTRAFILTRATION VOLUME WAS 1946ML, GIVING A DRAIN VOLUME OF 4946ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE UPDATED THE PERITONEAL DIALYSIS (PD) NURSE WITH THE IIPV IDENTIFIED IN THE HC DEVICE LOG AND PROBABLE CAUSE.

    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 63 YR