BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1813611 · Received August 25, 2010

    Report

    Report Number
    1423500-2010-02855
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    April 27, 2010
    Report Date
    August 2, 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). EVALUATION SUMMARY: THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST BUT FAILED THE RITE FUNCTIONAL TEST DUE TO BEING RECEIVED INOPERATIVE FOR A SYSTEM ERROR 2069 ALARM (SOFTWARE ERROR). THE DEVICE WAS MADE OPERATIVE TO FACILITATE TESTING; ONCE OPERATIVE, THE DEVICE MET THE REMAINDER OF THE RITE FUNCTIONAL TEST REQUIREMENTS. REVIEW OF THE RETURNED DEVICE LOGS REVEALED MULTIPLE ANOMALIES AND DRAIN VOLUMES THAT MET THE INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. REVIEW OF THE DEVICE?S PREVIOUS SERVICE RECORD REVEALED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO BEING RELEASED FROM THE TAMPA BAY FACILITY. NO ISSUES WERE IDENTIFIED THAT COULD HAVE CAUSED THE ADDITIONAL DRAIN VOLUMES MEETING IIPV CRITERIA FOUND IN THE DEVICE LOGS. THE CAUSE OF THE DEVICE LOG ANOMALIES AND MULTIPLE DRAIN VOLUMES MEETING IIPV CRITERIA WAS UNDETERMINED. 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 INFORMATION: PRODUCT SURVEILLANCE FOLLOWED UP WITH THE PD CLINIC AND PROVIDED THE NURSE WITH THE DEVICE EVALUATION RESULTS. THE NURSE WAS UNAWARE OF ANY ISSUES OR PROBLEMS ASSOCIATED WITH THE REPORTED ISSUE. THE HP IS DOING WELL WITH THEIR CURRENT THERAPY AND CONTINUES TO USE THE CYCLER FOR PD THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A RELOAD CASSETTE ERROR MESSAGE ON THE HOMECHOICE (HC) WHERE A PATIENT REPORTED THE LINE WAS FULL AND WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    TWENTY THREE INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 1 OF 23. THE IIPV OCCURRED ON (B)(6) 2010 DURING CYCLE 1. THE ULTRAFILTRATION (UF) WAS 1,185,326 ML, WHICH MEETS BAXTER?S IIPV CRITERIA. THIS VOLUME APPEARS TO BE AN ANOMALY BASED ON THE AMOUNT OF SOLUTION USED DURING A THERAPY AS WELL AS THE PHYSIOLOGY OF THE HUMAN BODY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED WITH THIS EVENT OR ANY OF THE OTHER EVENTS.

    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 65 YR