BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1980004 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01558
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER TAMPA BAY FACILITY FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST AND THE HOMECHOICE RITE ELECTRICAL TEST. THE REPORTED ISSUE WAS NOT DUPLICATED DURING THE RITE FUNCTIONAL TEST. THE REPORTED ISSUE WAS CONFIRMED BY REVIEW OF THE LOGS BUT NOT DUPLICATED DURING THE PAL EVALUATION. INTERNAL/EXTERNAL INSPECTION PER (B)(4) FOUND NO ISSUES. TWO SHORT THERAPIES WITH HEATER BAGS AT ROOM TEMPERATURE WHILE BEING MONITORED USING CRT (CYCLER REMOTE TOOLBOX) 8.800 'TEMPMON'; ALL TEMPERATURES DISPLAYED WERE IN NORMAL OPERATING SPECIFICATIONS, BAG SENSORS WERE WITHIN 3 ? C THROUGH BOTH THERAPIES AND DEVICE DOES NOT DELIVER FLUID OUTSIDE OF COMFORT CONTROL SETTING (37 ? 3? C). RESISTANCE MEASURED ACROSS HEATER ELEMENTS WAS 60?, WHICH IS WITHIN SPECIFICATION OUTLINED IN BAXTER HOMECHOICE ERROR CODE DOCUMENT. VOLTAGES WERE THEN MEASURED ON THE DIGITAL PCB AND FOUND TO BE STABLE AND WITHIN SPECIFICATION. DETAILED INSPECTION OF BOTH THE THERMAL PCB AND ACCOMP PCB REVEALED NO ISSUES. THE ASSIGNABLE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED; DEVICE FUNCTIONED NORMALLY DURING EVALUATION AND WAS WITHIN SPECIFICATIONS. A SERVICE HISTORY REVIEW WAS DONE AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF SE (B)(4). THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO SE (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2058 ALARM ON THE HOMECHOICE (HC) UNIT DURING FILL 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO THE HC. THE HP STATED THE HEATER BAG WAS COLD. THE TSR ADVISED A SWAP OF THE MACHINE. THE TSR INFORMED THE HP TO CONTACT THE NURSE TO PROGRAM THE NEW DEVICE AND TO USE MANUAL BAGS. THE TSR FURTHER ASSISTED THE HP TO END THE THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 59 YR