BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2111674 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06994
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 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 REPORTED ISSUE OF DEVICE PROGRAMMED FOR 5 CYCLES BUT CHANGES TO 4 CYCLES ONCE THERAPY STARTS 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. MULTIPLE SHORT SIMULATED THERAPIES WERE PERFORMED AND COMPLETED SUCCESSFULLY. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. A REVIEW OF THE DEVICE LOGS REVEALED THE OPERATOR CHANGED THE THERAPY VOLUME FROM 10500 TO 10000 ML. THIS WAS NOT ENOUGH TO COMPLETE 5 CYCLES AT 2000 ML EACH, PLUS A 300 ML LAST FILL. THEREFORE THE DEVICE COMPENSATED BY REDUCING THE NUMBER OF CYCLES TO 4. THE ASSIGNABLE CAUSE FOR DEVICE PROGRAMMED FOR 5 CYCLES BUT CHANGES TO 4 CYCLES ONCE THERAPY STARTS WAS DETERMINED TO BE USE ERROR; OPERATOR CHANGED THERAPY VOLUME FROM 10500 TO 10000 ML. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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, 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 THE PROGRAM WAS CHANGED ON A HOME CHOICE (HC) MACHINE DURING USE. THE HOME PATIENT (HP) STATED THAT THE HC WAS PROGRAMMED TO DO 5 CYCLES BUT CHANGED TO 4 CYCLES ON ITS OWN ONCE THERAPY WAS STARTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROGRAMMING FOR THE HC. THE TSR ASKED THE HP WHAT SIZE BAGS HE WAS USING. THE HP STATED THAT HE USED TWO 6 LITER BAGS. THE TSR EXPLAINED HOW THE HC CAN CALCULATE 5 CYCLES, AND THEN CHANGE TO 4 CYCLES. THE HP STATED THAT THE HC HAS BEEN FINE AND THEN IT JUST STARTED TO CHANGE CYCLES. THE TSR RECOMMENDED THAT THE HP CONTACT THEIR REGISTERED NURSE (RN). THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1