BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3170811 · Received May 23, 2013

    Report

    Report Number
    2021710-2013-00040
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K062093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTATION BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE, VERIFIED THE FIO2 OUTPUT DELIVERY INACCURACY AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY COMPONENT WITHIN THE GAS DELIVERY ENGINE. IN ADDITION THE DURING THE EXTENDED SYSTEM TEST, THE CAREFUSION FIELD SERVICE REP IDENTIFIED THAT THE DEVICE WOULD NOT PASS THE OXYGEN SENSOR CALIBRATION AND WOULD CONSTANTLY GIVE AN AUDIBLE AND VISUAL LOW FIO2 ALARM. THE AVEA VENTILATOR HAS THE OPTION FOR THE END USER TO DISABLE THE O2 ALARM IN THE EVENT OF AN OXYGEN SENSOR FAILURE WHILE THE VENTILATOR IS IN USE. HOWEVER, PER OPERATOR'S MANUAL, IF THE O2 ALARM IS DISABLED AN EXTERNAL ANALYZER SHOULD BE PLACED IN LINE IN THE BREATHING CIRCUIT UNTIL THE OXYGEN SENSOR HAS BEEN REPLACED. THE CAREFUSION FIELD SERVICE REP WAS NOT ABLE TO DETERMINE IF THE O2 ALARM WAS DISABLED AT THE TIME OF THE EVENT. A F/U MEDWATCH REPORT WILL BE SUBMITTED ONCE THE GAS DELIVERY ENGINE EVALUATION IS COMPLETE. PER AVEA OPERATOR'S MANUAL: LOW O2% (LOW FIO2) IS A HIGH PRIORITY AUDIBLE/VISUAL ALARM. LOW FIO2 IS DISPLAYED AND A HIGH PRIORITY TONE SOUNDS IF THE MONITORED DELIVERED O2% FALLS BELOW THE SET FIO2 MINUS 6% OR 18% FIO2, WHICHEVER IS GREATER.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REP. "ACCORDING TO THE THERAPIST, THE VENTILATOR WAS ON A (B)(6) AND THE (B)(6) STARTED TO DESATURATE, AT WHICH POINT THEY INCREMENTALLY INCREASED THE FIO2 TO 100%. THE (B)(6) CONTINUED TO DESATURATE AND THE THERAPIST NOTED THERE WAS NO OBVIOUS PROBLEMS WITH THE VENTILATOR. AT THE DOCTOR'S REQUEST, THEY SWAPPED OUT THE VENTILATOR. AS SOON AS THE (B)(6) WAS PLACED ON ANOTHER UNIT, THE (B)(6) SATURATION INCREASED. THEY WERE ABLE TO WEAN THE PT DOWN TO 21% AT THE END OF THE SHIFT." THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP IN RESPONSE TO A CONVERSATION WITH THE USER FACILITY REP. "THEY REPORTED THAT WHILE IN USE IN THE (B)(6), PT HAD DE-SATURATED DESPITE FIO2 BEING INCREASED TO 100%. VENT WAS IN PRESSURE SIMV. PT WAS REMOVED FROM VENT AND BAGGED WHILE BEING TRANSFERRED TO ANOTHER AVEA. AFTER BEING PLACED ON SECOND WITH AVEA SAME SETTINGS, THEY WERE ABLE TO WEAN O2 DOWN TO 50% WITHIN 15 MINUTES AND FURTHER REDUCED IT TO 21% BY THE END OF SHIFT. PT IS OK. I SPOKE TO THERAPIST WHO WAS PRESENT DURING THIS AND SHE REPORTED THAT "THERE WAS NO APPARENT PROBLEM WITH THE FIRST VENT AND THAT NO ALARMS WERE OCCURRING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228859 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU