BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1920356 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06774
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 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 WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST BUT FAILED THE RITE ELECTRICAL GROUND BOND TEST. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE. THE RESISTANCE BETWEEN THE POWER ENTRY MODULE AND THE DOOR POST WAS FOUND TO BE WITHIN THE GROUND BOND SPECIFICATION. AN INTERNAL INSPECTION OF THE DEVICE REVEALED NO PROBLEMS. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE RITE FAILURE. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - GROUND BOND WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED; THE PREVIOUS RETURN OF THE DEVICE WAS FOR FAILED GROUND BOND TEST, HOWEVER, THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE (B)(6) FACILITY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE/PRODUCT SAMPLE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. 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

    DURING EVALUATION OF THE HOME CHOICE (HC) DEVICE, THE (B)(6) LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO A FAILURE OF THE GROUND BOND PERFORMANCE SPECIFICATION. DURING A CALL TO THE NURSE TO FOLLOW-UP; THE RN STATED THE HOME PATIENT (HP) HAD PASSED AWAY ON (B)(6) 2010 DUE TO CEREBRAL VASCULAR ACCIDENT (CVA) OR STROKE WITH CRANIAL HEMORRHAGE. THE HP WAS NOT ATTACHED TO THE CYCLER AT THE TIME OF DEATH AND THERE WERE NO CHANGES REPORTED TO HER THERAPY PRIOR TO DEATH. THE HP HAD BEEN REMOVED FROM THERAPY AND PLACED OF HOSPICE PRIOR TO DEATH.

    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 56 YR (B)(4) 1.5% LO/CAL 5L/5L DIANEAL (B)(4) 2.5%