BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1822144 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03053
    Event Type
    Death
    Date Received
    September 1, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)THE DEVICE HAS BEEN RECEIVED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL). UPON COMPLETION OF THE EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL) AND WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURNED INSTRUMENT TEST EVALUATION (RITE) TESTING. THE DEVICE PASSED THE RITE ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF THE DEVICE'S ALARM LOG CONFIRMED THE LDV ALARM REPORTED ON (B)(6) 2010. REVIEW OF THE THERAPY AND EVENT LOGS REVEALED THE LAST THERAPY PERFORMED USING THE DEVICE WAS INITIATED (B)(6) 2010 ENDING (B)(6) 2010 AND WAS SUCCESSFULLY COMPLETED. PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF LOW DRAIN VOLUME ALARMS. THE DEVICE FUNCTIONED AS DESIGNED. REVIEW OF THE DEVICE'S PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE LOW DRAIN VOLUME ALARMS OR THE PATIENT EXPIRATION. THE ASSIGNABLE CAUSE OF THE LOW DRAIN VOLUME ALARM WAS DETERMINED TO BE A CATHETER RELATED ISSUE. 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 RENQCAPA-(B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS DEVICE.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REQUESTING ASSISTANCE WITH A LOW DRAIN VOLUME THAT APPEARED WHILE USING THE HOMECHOICE (HC) CYCLER DURING THE INITIAL DRAIN. THE CAREGIVER STATED THE PATIENT DID A 1500ML LAST FILL AND DRAINED OUT 15ML. THE CAREGIVER STATED THE PATIENT HAD NOT HAD A BOWEL MOVEMENT SINCE YESTERDAY AND HAD FALLEN EARLIER. GTS ASSISTED THE CAREGIVER TO PERFORM A TEST FILL OF 186ML AND WAS ONLY ABLE TO DRAIN 142ML. THE CAREGIVER AGREED TO CALL THE PATIENT?S NURSE IF THE PATIENT WAS UNABLE TO DRAIN. DURING A FOLLOW UP CALL, FACILITY NURSE STATED THE EVENT WAS RESOLVED AND THE PATIENT WAS ABLE TO RESUME THERAPY WITHOUT COMPLICATION. THE NURSE ADVISED THAT THE PATIENT LATER EXPIRED WAS DUE TO CARDIAC ARREST. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    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 72 YR Death| H (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%