BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1844343 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03710
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 1, 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 PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRAPERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO INSUFFICIENT DRAIN: ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. A SERVICE HISTORY REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE CURRENT 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). ON (B)(6) 2011, BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) AND PROVIDED THE RESULTS OF THE EVALUATION. THE PD RN STATED SHE WAS NOT AWARE OF THE PATIENT HAVING ANY SYMPTOMS AROUND THE TIME OF THE INCIDENT AND STATED THE PATIENT HAS BEEN FINE AND CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE (HC) DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 4. THE DRAIN VOLUME WAS 4448 ML (MILLILITERS). THE PROGRAMMED FILL VOLUME WAS 2500ML. 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 62 YR