BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1920147 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06744
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 17, 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
    SERVICE AND TESTING PERSONNEL

    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER (B)(4) FACILITY FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST AND THE HOMECHOICE RITE ELECTRICAL TEST. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCED TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE ULTRAFILTRATION VOLUME WAS 660 ML. THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(4) 2010, PRODUCT SURVEILLANCE SPOKE WITH NURSE AND PROVIDED THE RESULTS OF EVALUATION. THE NURSE LOOKED UP THE SERIAL NUMBER FOR THE HOMECHOICE DEVICE ((B)(4)) AND REVIEWED HER DOCUMENTATION. THE NURSE STATED THAT NO ADVERSE EVENTS WERE REPORTED FOR THE OCCURRENCE DATE OF (B)(6) 2010. THE NURSE CONFIRMED THAT NO MEDICAL INTERVENTION OR PATIENT INJURY WAS REPORTED. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1