BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1973401 · Received January 30, 2011

    Report

    Report Number
    1423500-2011-01270
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    December 24, 2010
    Report Date
    January 10, 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). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS FOUND IN THE DEVICE LOGS. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN / FALSE EMPTY DETECT DUE TO USE ERROR AS THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW (50%). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS REPORT. 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

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 17. THE PATIENT'S ULTRAFILTRATION IS 59ML, INDICATING THE PATIENT DRAINED 59ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 140ML, THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON 1/26/2011. ACCORDING TO THE NURSE THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE PATIENT HAS TEMPORARILY STOPPED PERITONEAL DIALYSIS DUE TO UNRELATED ISSUES; HOWEVER, THE PATIENT WILL BE RESTARTING THERAPY NEXT WEEK. NO FURTHER INFORMATION IS AVAILABLE.

    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 10 MO