BEUDAMED
    FDA Adverse Event Death Summary report: N

    OHMEDA MEDICAL

    MDR report key: 3241206 · Received July 17, 2013

    Report

    Report Number
    2021710-2013-00054
    Event Type
    Death
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE OEM CUSTOMER OR MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE USER FACILITY VIA E-MAIL. (B)(4). ON (B)(4) 2013, CAREFUSION SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT INCLUDING THE PRIMARY AND SECONDARY CAUSES OF THE PATIENT EXPIRATION AND A DETERMINATION OF, IF THE REPORTED FAILURE CAUSED OR CONTRIBUTED TO THE DEATH. ON (B)(6) 2013, THE USER FACILITY RESPONDED TO THE LETTER AND ONLY PROVIDED THE DEVICE MODEL, DEVICE SERIAL NUMBER AND THE FOLLOWING STATEMENT "BLENDER UNRESTRICTED NO REGULATION." IN ADDITION CAREFUSION HAS REQUESTED THE RETURN OF THE MICROBLENDER FOUR TIMES WITHOUT SUCCESS; ONCE VIA EMAIL ON (B)(4) 2013 AND THREE TIMES VIA TELEPHONE (B)(4) 2013.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS COPIED FROM A USER FACILITY E-MAIL RECEIVED BY OEM CUSTOMER ON (B)(4) 2013 WHO THEN FORWARDED TO CAREFUSION ON (B)(4) 2013. "THERE WAS AN ISSUE THIS MORNING THAT RESULTED IN A PATIENT DEATH WHERE THE BLENDER THAT IS ATTACHED TO THE SIDE OF A GIRAFFE OMNIBED (SN (B)(4)) THAT WHEN AIR AND O2 WERE CONNECTED, THERE WAS NO RESTRICTION AND UNABLE TO REGULATE WITH THE KNOBS. CUSTOMER DID NOT HAVE THE SERIAL NUMBER ON THE BLENDER ONLY THAT IT SAID OHMEDA MEDICAL. NURSES REPORTED THAT THEY WENT THROUGH MULTIPLE MOTTLES (APPROX. 6 E CYLINDERS) OF O2 WHEN TRANSPORTING THE BABY FROM THE DELIVERY AREA TO THE NURSERY. THE EVENT HAPPENED ON (B)(6) 2013 BETWEEN 4:00 AM AND 5:00 AM. THE UNIT HAS BEEN TAKEN OUT OF SERVICE AND IS ON WHAT THE BIOMED CALLED LOCK DOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332959 OHMEDA MEDICAL MIXER,BREATHING GASES, ANESTHESIA INHALATION / BZR BZR CAREFUSION M 2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GIRAFFE ONMIMED S/N (B)(4)