BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 3010986 · Received March 8, 2013

    Report

    Report Number
    2021710-2013-00014
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION REPORTED TO CAREFUSION (B)(4) (OUR REPRESENTATIVE IN (B)(4)) BY THE USER FACILITY AND RELAYED TO CAREFUSION TECHNICAL SUPPORT VIA E-MAIL. (B)(4). CAREFUSION HAS REVIEWED THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY AND DETERMINED THAT THERE IS NO REPORT OF A FAILURE OF THE CAREFUSION SIPAP DRIVER OR THE CAREFUSION INFANT FLOW LP SERIES, GENERATOR AND NASAL MASK TO PERFORM AS INTENDED. IT APPEARS THAT WHEN THE FISHER AND PAYKEL MR850 HUMIDIFIER AND PATIENT CIRCUIT WERE SET UP FOR USE WITH THE CAREFUSION SIPAP DRIVER AND INFANT FLOW LP SERIES, GENERATOR AND NASAL MASK. ONE OF THE TEMPERATURE PROBES WAS NOT INSERTED INTO THE APPROPRIATE TEMPERATURE PROBE PORT ON THE PATIENT CIRCUIT. THUS THE TEMPERATURE PROBE WAS LYING ON THE FLOOR READING THE AMBIENT TEMPERATURE AT THE FLOOR INSTEAD OF THE TEMPERATURE OF THE SATURATED GAS IN THE PATIENT CIRCUIT. RESULTING IN THE EVENT AS REPORTED. AT PRESENT CAREFUSION HAS ZERO LIKE REPORTED EVENTS AND FEEL THAT THIS EVENT IS DIRECTLY RELATED TO END USER SET UP/CONFIGURATION OF THE PATIENT CIRCUIT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CAREFUSION (B)(4) (OUR REPRESENTATIVE IN (B)(4)) BY THE USER FACILITY AND RELAYED TO CAREFUSION TECHNICAL SUPPORT VIA E-MAIL. "WE RECEIVED THIS INFORMATION FROM (B)(6), WITH THEIR COMMENT THAT THEY HAD SENT THIS COMPLAINT TO FISHER AND PAYKEL, JUST WANTED TO INFORM US WHAT HAD HAPPENED. THEY TOLD US THIS WEEK THAT THEY MADE SOME TESTS OF THE HUMIDIFIER AND ACCORDING TO THEM, IN THIS SITUATION, THE FLOW THAT LEAVES THEIR PATIENT CIRCUIT HAS A HEAT OF UP TO +48 DEGREES! IF THAT'S THE TRUTH, I'M NOT SURPRISED THAT THIS LITTLE BABY GOT VERY SEVERE BURN ON THE NOSE. I JUST WANTED TO INFORM YOU SINCE THE 850 IS CONNECTED TO OUR SIPAP/LP, AND YESTERDAY, I ALSO GOT THIS PICTURE FROM THE DEPARTMENT. WHAT THEY DID TELL ME, IS THAT IT LOOKS MUCH BETTER NOW, BUT THIS PICTURE IS THE WORST THING I HAVE EVER SEEN. "BRIEF HISTORY: BABY DELIVERED AT (B)(6) GRAVE ABOUT (B)(6), DELIVERED VIA CAESAREAN SECTION AT 2:01. AT THE AGE OF ABOUT (B)(6) OF ARRIVAL TO THE DEPARTMENT, THEN PUT THE BABY IN SIPAP WITH MASK. F AND P HOSES FOR IT'S INTENDED PURPOSE AND CARE FUSION LP SYSTEM. JOURNAL NOTES AT 6.22 "FULL BRIGHT RED SKIN." AT ABOUT 08.00 NOTED THAT THE NOSE IS BRIGHT RED AND MOIST, ABRADED EPIDERMIS, NOSE WASHED M NACL AND MEPITEL PUT ON, CONTINUED CPAP THERAPY WITH THE SAME EQUIPMENT. ACCORDING TO RECORDS, INTUBATED THE CHILD AT ABOUT (B)(6) OF AGE TO THE CHILD IN NEED OF RESPIRATORY CARE. THE BABY IS INTUBATED NASALLY. THE TUBE IS TAPED "DOWN" TO RELIEVE THE NOSE. ON (B)(6) DRY TIP OF THE NOSE LOOKS MORE LIKE A HEMATOMA. ON (B)(6) TIP OF THE NOSE STARTS TO LOOK "WRINKLED" OUT-PHOTO TAKEN. ON (B)(6) EAR DOCTOR DETERMINES THAT THE CHILD MUST REINTUBERAS ORALLY TO RELIEVE THE NOSE, WHICH IS DONE. IN RETROSPECT, IT TURNED OUT THAT THE FIRST HOUR IS NOT TEMP PROBE AT THE HOUSE SAT ON THE GROUND WITHOUT HANGING FREELY IN THE ROOM. THE MEASURED TEMPERATURE IS 23 DEGREES AFTER ABOUT AN HOUR WHEN DEBUGGING, SO VERY YOU KNEW (IT'S VERY TO DO WHEN THE KIDS JUST COME) DETECTED THE ERROR AND THE TEMP PROBE IS PUT IN PLACE WHEN THE TEMPERATURE SHOWN IS ABOUT 37 DEGREES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100628 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION SIPAP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other FISHER & PAYKEL MR850 HUMIDIFIER