BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1904753 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05468
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 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 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. THIS MDR WAS SUBMITTED ON (B)(4) 2010; HOWEVER, DUE TO A FAILURE TO RECEIVE ANY ACKNOWLEDGEMENTS, THIS MDR IS BEING RESUBMITTED ON (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE. THE DEVICE FAILED THE TEMPERATURE VERIFICATION TEST DUE TO TAKING LONGER THAN 30 MINUTES. THE ASSIGNABLE CAUSE FOR THE FAILED TEMPERATURE VERIFICATION TEST WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE FAILURE. 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). UPON FURTHER INVESTIGATION BY BAXTER, IT WAS DETERMINED THAT THIS INCIDENT INVOLVED A RITE ENCOUNTER ERROR PREVENT RITE (B)(6) COMPLETION-FAILED FUNCT SPECIFICATION / TIME OUT DRAIN 1 NOT A RETURNED INSTRUMENT TEST/EVALUATION (RITE) TESTING FAILURE -THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION AS INITIALLY REPORTED. THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR TIMING OUT DURING DRAIN, BUT PASSED THE RITE ELECTRICAL TEST. THE PAL EVALUATED THE DEVICE. ACCURACY CONFIRMATION WAS PERFORMED AND THE DEVICE PASSED. AN INTERNAL INSPECTION REVEALED NO PROBLEMS. THE ASSIGNABLE CAUSE FOR THE RITE TEST FAILURE - TIMEOUT DURING DRAIN WAS DETERMINED TO BE THE PUMP. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE FAILURE.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE FOLLOWING FAILURE: THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO