BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1833014 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03394
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 27, 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 RETURNED INSTRUMENT TEST (RITE) ELECTRICAL TEST BUT FAILED THE RITE FUNCTIONAL TEST DUE TO AN UNRELATED ALARM. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO IIPV. THE CAUSE WAS DETERMINED TO BE: INSUFFICIENT DRAIN-FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW (75%). THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A REVIEW OF THE PREVIOUS SERVICE RECORD REVEALED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF IIPV. 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 4 AND POST THERAPY. DRAIN 4 VOLUME WAS 2764ML PLUS A POST THERAPY DRAIN OF 1661ML GIVING A TOTAL DRAIN OF 4425ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS RN AND INFORMED HER OF THE IIPV IDENTIFIED IN THE THERAPY LOG. THE RN REPORTED THIS PATIENT WAS NEW TO THE CYCLER AND WAS HAVING SLIGHT DRAINING ISSUES, NOT RELATED TO THE CYCLER AT THIS TIME. THE RN STATED ALL THEIR PATIENTS' MINIMUM DRAIN VOLUME PERCENTAGES SETTINGS ARE SET AT 75%. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT AND THE RN REPORTED THE PATIENT IS DOING FINE AND CONTINUES TO USE THE CYCLER WITH NO REPORTED PROBLEMS.

    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 73 YR