BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1913176 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06469
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 9, 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). BAXTER PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. ACCORDING TO THE NURSE THE PATIENT HAS NOT REPORTED ANY SYMPTOMS OF FEELING OVERFILLED. THE PATIENT HAS RESUMED THERAPY WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. 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. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN / USE ERROR AS THE TIDAL ULTRAFILTRATION REMOVAL WAS SET TOO LOW (0ML). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. A LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS REPORT. 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, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010 AT 23:43 WITH ULTRAFILTRATION OF 1500ML DURING CYCLE 4. THIS EVENT MEETS OVERFILL CRITERIA.

    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