BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2222121 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11193
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED BY THE PRODUCT ANALYSIS LAB (PAL) AND EVALUATED FOR A REPORTED PROGRAM CHANGED BY DEVICE ISSUE. THE REPORTED PROGRAM CHANGED BY DEVICE ISSUE WAS CONFIRMED IN THE LOGS BUT NOT DUPLICATED DURING THE EVALUATION. THE DEVICE PASSED THE RETURNED INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE DEVICE ALSO PASSED THE INTERNAL/EXTERNAL INSPECTION TESTS. THE REVIEW OF THE LOGS SHOWED MULTIPLE BYPASSES IN ALL DOCUMENTED THERAPIES. AFTER MULTIPLE BYPASSES, IT IS NORMAL FOR THE DEVICE TO ADD CYCLES TO MAINTAIN THE INTEGRITY OF THE PROGRAMMED THERAPY. BASED ON THE EVALUATION RESULTS, THE ASSIGNABLE CAUSE FOR THE REPORTED PROGRAM CHANGED BY DEVICE ISSUE WAS DETERMINED TO BE NORMAL DEVICE FUNCTION. AFTER EVALUATION, THE DEVICE WAS FORWARDED TO SERVICE WITH NO SPECIAL INSTRUCTIONS. 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). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PROGRAM CHANGED BY DEVICE ON THE HOME CHOICE (HC) MACHINE DURING DRAIN CYCLES. PARTIAL PROGRAMMING WAS RETRIEVED TO REVIEW ISSUES WITH CYCLES ON THE HC. THE HP STATED THAT THE HC WAS SHOWING 5 CYCLES INSTEAD OF 4. THE HP CALLED HER PDRN, WHO SUGGESTED THAT THE HP GET A NEW CYCLER. THE TSR INITIATED A SWAP OF THE MACHINE. THE HP WAS TO HAVE THEIR PDRN ASSIST THEM IN PROGRAMMING THE NEW HC SINCE ONE OF THE ISSUES WITH THE HC IS A POSSIBLE PROGRAMMING ISSUE. THERE WAS A PATIENT INVOLVED AND WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1