BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1883766 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04957
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    July 7, 2010
    Report Date
    October 6, 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 MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE INSUFFICIENT DRAIN: FALSE EMPTY DETECT AND USE ERROR: INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE PATIENT'S FILL VOLUME WAS 2200ML. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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)(4) 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 ANY PATIENT SYMPTOMS AROUND THE TIME OF THE INCIDENT AND STATED THE PATIENT HAD BEEN ON HEMODIALYSIS FOR QUITE SOME TIME AND WAS CONTINUING HEMODIALYSIS CURRENTLY.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND 4 INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS. THIS IS REPORT 3 OF 4 WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE DRAIN VOLUME WAS 5340ML. 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