BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 2159411 · Received July 6, 2011

    Report

    Report Number
    9616240-2011-00003
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    PMA / PMN Number
    K070643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, ALL THREE INNOVA MACHINES WERE INSPECTED BY A (B)(4) TECHNICIAN (LOCAL DISTRIBUTOR IN (B)(4)). HE VERIFIED THE MACHINES IN ACCORDANCE WITH THE INNOVA SERVICE MANUAL AND FOUND THEM TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. HE ALSO PERFORMED A SIMULATED TREATMENT AND VERIFIED THAT THE MACHINES WERE FUNCTIONING PROPERLY. NO MACHINE MALFUNCTION OR OTHER ANOMALOUS MACHINE BEHAVIOR WAS FOUND. ALL THE DISPOSABLES USED DURING THE REPORTED EVENTS WERE GAMBRO PRODUCTS EXCEPT FOR THE BLOODLINES. ACCORDING TO INNOVA OPERATOR MANUAL, CHAPTER "INTRODUCTION", THE FOLLOWING WARNING STATES: "THE USE OF THE GAMBRO CARTRIDGE BLOOD SET DESIGNED FOR PHOENIX MACHINE HAS BEEN TESTED AND VALIDATED TO PROVIDE SAFE AND PROPER FUNCTIONING OF THE SYSTEM. THE MANUFACTURER HAS NOT VALIDATED THE USE OF BLOODLINES OTHER THAN THOSE SPECIFIED IN THIS MANUAL. THE MFR DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR USE OF BLOODLINE OTHER THAN THE GAMBRO CARTRIDGE BLOOD SET. IT IS THE RESPONSIBILITY OF THE USER TO VALIDATE THAT OTHER BLOODLINES PROVIDE SAFE AND EFFECTIVE PERFORMANCE."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE HEMOLYSIS EVENTS WHICH OCCURRED BETWEEN (B)(6) 2011 WHILE USING THREE DIFFERENT INNOVA MACHINES AT (B)(6) HOSPITAL (SEE ALSO MDR 9616240-2011-00004 AND 9616240-2011-00005). THE PATIENTS WERE TRANSFERRED TO THE INTENSIVE CARE UNIT. NO FURTHER MEDICAL OR CLINICAL DATA HAS BEEN PROVIDED. GAMBRO HAS FORMALLY REQUESTED ADDITIONAL INFORMATION ABOUT THE SPECIFIC PRODUCTS INVOLVED AND THE MEDICAL AND CLINICAL INFORMATION SPECIFIC TO EACH EVENT. ALL THE DISPOSABLES USED BY THIS FACILITY WERE ORIGINAL GAMBRO PRODUCTS EXCEPT FOR THE BLOODLINES WHICH WERE MANUFACTURED AND SUPPLIED BY AN INDEPENDENT THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT KDI GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization BICART: UNKNOWN LOT