BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1844960 · Received September 27, 2010

    Report

    Report Number
    1423500-2010-03741
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 2, 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 CUSTOMER DISCONTINUED USE OF THE HOMECHOICE DEVICE AND RETURNED THE DEVICE. RETURN INSTRUMENT TEST/EVALUATION (RITE) WAS PERFORMED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE FAILED RITE FUNCTIONAL TEST DUE TO HEATER BAG TEMPERATURE FAILED PERFORMANCE SPEC, AND PASSED RITE ELECTRICAL TEST. THE ASSIGNABLE CAUSE FOR THE RITE ENCOUNTERED ISSUE WAS UNDETERMINED; THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ENCOUNTERED DIFFICULTY. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT340 BREATHING CIRCUITS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO A FAILURE OF THE HEATER BAG TEMPERATURE FAILED PERFORMANCE SPECIFICATION-FLUID DELIVERED OUT OF SPECIFICATIONS. FOLLOW UP WITH THE NURSE REVEALED THAT THE PATIENT IS NO LONGER PERFORMING PERITONEAL DIALYSIS. 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 56 YR