BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1960626 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00577
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 20, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS LABORATORY (PAL) EVALUATED THE DEVICE. THE DEVICE FAILED THE HOMECHOICE RETURNED INSTRUMENT TEST EVALUATION (RITE) FUNCTIONAL TEST FOR RITE ELECTRICAL GROUND BOND TEST. THE RESISTANCE READING BETWEEN THE POWER ENTRY MODULE AND THE DOOR POST WAS OUT OF SPECIFICATION. THE GROUND WIRE BONDING SCREW ON THE DOOR FRAME WAS FOUND TO BE LOOSE. THE SCREW WAS TIGHTENED AND THE RESISTANCE READING WAS WITHIN THE GROUND BOND SPECIFICATION. THERE WERE NO OTHER PROBLEMS FOUND DURING AN INTERNAL INSPECTION. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - GROUND BOND WAS DETERMINED TO BE A LOOSE GROUND WIRE BONDING SCREW ON THE DOOR FRAME. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE ELECTRICAL FAILURE. 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). DEVICE EVALUATION IS IN PROGRESS; HOWEVER, NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE EVALUATION AND BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE THE DEVICE FAILED THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY.

    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 HOMECHOICE APD SYSTEM (B)(4) / REFURBISHED