BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1030287 · Received April 15, 2008

    Report

    Report Number
    1423500-2008-00242
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 5, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) #K923065. THE RETURNED HOMECHOICE MACHINE WAS EVALUATED. THREE SIMULATED PATIENT THERAPIES WERE PERFORMED USING THE PATIENT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE'S PNEUMATIC SYSTEM WAS EVALUATED, NO PROBLEMS WERE REVEALED AND ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION WAS PERFORMED. NO PROBLEMS WERE REVEALED AND ALL CONNECTION WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PAST TRENDS. NUMEROUS LOW DRAIN VOLUME ALARMS WERE OBSERVED IN THE DEVICE LOGS. REVIEW OF THE CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG REVEALED THAT IN DRAIN 5 OF THE THERAPY STARTED IN 2008, AN OVERFILL HAD OCCURRED. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE LAB DETERMINED THE MOST PROBABLE CAUSE OF THE OVERFILL TO BE INSUFFICIENT DRAIN WHEN MULTIPLE CYCLES ADVANCED TO FILL WHEN A SLOW / NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE LAB DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA FOR REFURBISHMENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE RETURNED HOMECHOICE MACHINE, AN OVERFILL WAS DISCOVERED IN DRAIN 5 OF THERAPY STARTED IN 2008 DURING REVIEW OF THE CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG. THE HOME PATIENT'S PROGRAMMED FILL VOLUME IS 2000 ML AND THE MINIMUM DRAIN VOLUME PERCENTAGE IS 85%. THE UF READING IN DRAIN 5 WAS 832 INDICATING THAT THE HOME PATIENT DRAINED 832 ML MORE THAN THEIR PROGRAMMED FILL VOLUME, FOR A TOTAL DRAIN OF 2832 ML. PRODUCT SURVEILLANCE PLACED A FOLLOW UP CALL TO THE HOME PATIENT'S NURSE REGARDING THIS ISSUE AND SUGGESTED RE-EVALUATING THIS HOME PATIENT'S MINIMUM DRAIN VOLUME PERCENTAGE TO HELP PREVENT POSSIBLE OVERFILL IN THE FUTURE. THE NURSE STATED SHE WOULD SPEAK WITH THE HOME PATIENT AND ADJUST HIS MACHINE AS NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT, ACCORDING TO THE HOME PATIENT'S NURSE. PRODUCT SURVEILLANCE THEN FOLLOWED UP WITH THE HOME PATIENT. HE STATED HE HAD NO SYMPTOMS ASSOCIATED WITH THE OVERFILL DISCOVERED. HIS REPLACEMENT MACHINE IS WORKING WELL AND THERAPY IS GOING FINE. HE COULD NOT RECALL ANY FURTHER DETAIL REGARDING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1