BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1920378 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06777
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 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 WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE FAILED THE (B)(4) (RETURN INSTRUMENT TEST / EVALUATION) (B)(4) TEST. THE PAL EVALUATED THE DEVICE. GROUND BUS RESISTANCE WAS MEASURED AND FOUND TO BE WITHIN GROUND BOND SPECIFICATIONS. THE ASSIGNABLE CAUSE FOR (B)(4) TEST FAILURE - GROUND BOND WAS UNDETERMINED. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING EVALUATION OF A HOMECHOICE (HC), THE BAXTER PRODUCT ANALYSIS LABORATORY DETERMINED THE HC FAILED THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) DUE TO A GROUND BOND FAILING PERFORMANCE SPECIFICATIONS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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