BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRANUFLO POWDER CONCENTRATES AND MIXER

    MDR report key: 4478030 · Received February 2, 2015

    Report

    Report Number
    2937457-2015-00113
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 21, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K911459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY AND F/U WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION AND UPON RECEIPT OF ADDITIONAL INFO.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. THE SERIAL NUMBER FOR THE MACHINE WAS NOT PROVIDED THEREFORE THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THIS EVENT IS BEING INVESTIGATED VIA A CAPA.

    Description of Event or Problem · 1

    FRESENIUS MEDICAL CARE NORTH AMERICA MARKETING WAS NOTIFIED BY OUR CUSTOMER, FRESENIUS MEDICAL SERVICES (FMS), ON (B)(4) 2015 OF AN ISSUE PERTAINING TO THE NEUTRALIZATION PROCESS AS OUTLINED IN THE OPERATORS MANUALS FOR FRESENIUS DISSOLUTION UNITS. FMS WAS CONCERNED ABOUT THE GENERATION OF CO2 WHILE FOLLOWING THE NEUTRALIZATION PROCESS AS DESCRIBED IN THE FRESENIUS DISSOLUTION UNITS OPERATORS MANUALS. AS A RESULT, OUR CUSTOMER FMS CONTACTED A 3RD PARTY CONSULTING FIRM SPECIALIZING IN INDUSTRIAL HYGIENE TO MONITOR CO2 LEVELS WHEN PERFORMING THE NEUTRALIZATION PROCESS AT ONE OF THEIR FACILITIES. CO2 MONITORING DURING THE PROCESS CREATED AN EXCESS OF CO2 THAT PEAKED ABOVE THE IDLH OF 4% OF 40000PPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75690 GRANUFLO POWDER CONCENTRATES AND MIXER KPO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other