BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1873010 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04562
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RECEIVED AND EVALUATED. THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER TAMPA BAY FACILITY FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST ((B)(4)) AND THE HOMECHOICE RITE ELECTRICAL TEST ((B)(4)). DURING THE PAL EVALUATION A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. CRT (CYCLER REMOTE TOOLBOX) SOFTWARE INDICATED ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. A MANUAL DRAIN OFF-CYCLER WOULD NOT BE ABLE TO BE CONFIRMED IN THE LOGS NOR DUPLICATE DURING THE PAL EVALUATION. PROBABLE CAUSE: INSUFFICIENT DRAIN. ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SERVICE HISTORY REVIEW REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO IIPV. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE REGISTERED NURSE (RN) STATED THE HOME PATIENT (HP) DID A MANUAL DRAIN WITH MANUAL BAGS, DRAIN VOLUME (DV) 3900ML. THE PROGRAMMED FILL VOLUME WAS 2000ML. THIS EVENT MEETS OVERFILL CRITERIA. UPON FURTHER DISCUSSION WITH THE NURSE, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCOVERED THAT THERE WAS NO ALARMS. NO BYPASSES WERE PERFORMED. THE TSR SWAPPED OUT THE DEVICE FOR FURTHER EVALUATION. FOLLOW UP WITH THE PERITONEAL DIALYSIS NURSE (PDN) REVEALED THAT THE HP WAS ALSO FEELING FULL. THE PDN STATED SHE WAS UNAWARE IF THE HP RECEIVED THE REPLACEMENT HC BUT WAS DOING OK WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE MEANTIME. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR