BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2091920 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06094
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 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 SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF DISPLAY SHOWS 61 CYCLES INSTEAD OF 6 WAS CONFIRMED IN THE DEVICE LOGS BUT NOT DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE PAL EVALUATED THE DEVICE. THE DEVICE WAS POWER CYCLED SEVERAL TIMES WITH NO PROBLEMS. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. A REVIEW OF THE DEVICE LOGS REVEALED THE THERAPY MODE WAS CHANGED FROM CCPD TO TIDAL WHICH AUTOMATICALLY RESETS THE TIDAL VOLUME % AND TOTAL UF TO THE DEFAULT SETTINGS. AS A RESULT, THE NUMBER OF CYCLES INCREASED TO 61, CONFIRMING THE REPORTED ISSUE. HOWEVER, THE LOGS INDICATE ALL PREVIOUS THERAPIES WERE PROGRAMMED FOR 4 CYCLES, NOT 6 CYCLES AS REPORTED BY THE HOME PATIENT. THE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR; THERAPY WAS CHANGED FROM CCPD TO TIDAL MODE. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE HOMECHOICE/HOMECHOICE PRO PATIENT AT-HOME GUIDE WAS REVIEWED AND THE LABELING WAS FOUND TO BE SUFFICIENT. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PROGRAMMING ERROR ON A HOMECHOICE (HC) MACHINE DURING THE FIRST FILL CYCLE, PATIENT CONNECTED. THE HOME PATIENT (HP) STATED THAT THE DISPLAY SHOWS FILL 1/61 WHEN SHE NORMALLY HAS ONLY 6 CYCLES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER TO END OF THERAPY AND CYCLE POWER AGAIN TO CHANGE PROGRAM THERAPY CCPD/IPD TV = 9000 ML, FV = 2000 ML, LFV = 1000 ML, CYCLES = 61. THE TSR HAD THE HP CYCLE POWER AGAIN AND REMOVE THE PROCARD, AND GO BACK TO PROGRAM SETTINGS, CYCLES=61. THE TSR INITIATED A SWAP OF THE DEVICE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT BUT 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 58 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE