BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 3108828 · Received May 2, 2013

    Report

    Report Number
    2021710-2013-00029
    Event Type
    Other
    Date Received
    May 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION(S) WITH A USER FACILITY REP AND WRITTEN RESPONSES FROM THE USER FACILITY. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION TECH SUPPORT SPECIALIST AND INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE ALLEGATION OF PT EXPIRATION WAS REPORTED TO HAVE OCCURRED AT ANOTHER FACILITY OTHER THAN THE FACILITY NAMED IN THIS REPORT. THERE IS NO ALLEGATION OR INFORMATION ALLEGING THAT CAREFUSION PRODUCTS OR MATERIALS WERE INVOLVED IN, OR CONTRIBUTED TO THE REPORTED EXPIRATION. A CAREFUSION FIELD SERVICE ENGINEER VISITED THE FACILITY NAMED IN THIS REPORT AND CONFIRMED THAT THE VENTILATOR IS PERFORMING PER RELEASED LABELING. A FOLLOW-UP REQUEST FROM CAREFUSION TO THE FACILITY NAMED IN THIS REPORT SEEKING ADDITIONAL INFORMATION WAS SENT TO THE INITIAL REPORTER. INFORMATION ASSOCIATED WITH THE PT AND THE FACILITY NAME WHERE THE ALLEGED PT EXPIRATION OCCURRED HAS NOT BEEN PROVIDED AS OF 04/26/2013. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    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 USER FACILITY REP(S) ON (B)(4) 2013. "THE CUSTOMER CONTACTED AFTER HOURS SUPPORT WITH APPARENT ISSUES RELATED TO USING VOLUME GUARANTEE FEATURE AND SOME NEGATIVE PT OUTCOMES (PULMONARY INTERSTITIAL EMPHYSEMA/AIR LEAK SYNDROME) I PROVIDED SOME FEEDBACK PER OPERATORS MANUAL. THE CUSTOMER INDICATES SHE HAD CONTACTED FIELD CLINICAL OPS GROUP [NAME REMOVED] AND HE WOULD SCHEDULE CLINICAL VISIT. I SUGGESTED IF SHE COULD E-MAIL SOME VENT SPECIFIC SETTINGS WITH SN# ASSOCIATED WITH THIS ISSUE. I ALSO NOTED TO [NAME REMOVED] AN ON SITE VISIT BY OUR FIELD REP WOULD BE ALSO RECOMMENDED TO ENSURE UNIT IS FUNCTIONING ACCORDINGLY." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM AN E-MAIL RECEIVED FROM THE USER FACILITY ON (B)(6) 2013. "I AM SENDING AN E-MAIL IN RESPONSE TO OUR CONVERSATION TODAY REGARDING OUR CURRENT ISSUES WITH FIVE PT OUTCOMES OF PIE (PULMONARY INTERSTITIAL EMPHYSEMA)/AIR LEAK SYNDROME WHILE USING PSIMV/VG ON THE AVEA VENTILATOR, TWO OF WHICH RESULTED IN PTS EXPIRING. WE HAVE BEEN EXPLORING OUR INTERVENTIONS PRIOR TO THESE PTS BEING ON PSIMV/VG, BUT ARE ALSO CONSIDERING OUR VENT MANAGEMENT AND EFFECTIVENESS OF THE NEOFLOW SENSOR IN GUARANTEEING VOLUME WITH THE ALARMS THAT WE HAVE ENCOUNTERED. ALARMS HAVE CONSISTED OF FREQUENT VTE (CONCERNING THAT THIS IS A MODERATE NOT HIGH ALARM STATE AFTER 30 SECONDS) AND NOTED FREQUENT TO CONSTANT MESSAGING OF PRESSURE REGULATION VOLUME LIMITED, DESPITE A LEAK LESS THAN 60%, OUR PT'S HAVE SUFFERED FROM ATELECTRAUMA. ANOTHER COMMON FACTOR HAS BEEN AUTOCYCLING OF RR'S OF 80-100 BPM, DESPITE EVERYTHING FROM PT TO VENT CHECKING OUT (NEOFLOW SENSOR ZEROED). IT HAS BEEN SUGGESTED THAT WE PERFORM AN AVEA FLOW SENSOR HOT WIRE VERIFICATION TEST TO TEST THE EFFICIENCY AND/OR CLEANLINESS OF OUR CURRENT NEOFLOW SENSORS THAT ARE APPROX 6 MONTHS OLD. TYPICAL VENT SETTINGS ARE AS FOLLOWS: VT 5-6 ML/KG, PEEP 5-6 CMH20, ITIMES 0.35-0.40, PS 5-6, RR'S 20-30 BPM. PEAK LIMITS 25-35 CMH20 DEPENDENT ON PT COMPLIANCE. [NAME REMOVED] HAS ALSO MADE ME AWARE OF SOME POSSIBLE ADJUSTMENTS TO OUR ADVANCED SETTINGS THAT MAY BE HELPFUL IN THIS MATTER. [NAME REMOVED] HOPES TO VISIT OUR FACILITY WITHIN THE NEXT WEEK TO ASSIST US. WE ARE CURRENTLY ONLY USING PSIMV UNTIL WE HAVE A BETTER PLAN ON HOW TO REAPPROACH OUR USE OF PSIMV/VG FOR BETTER PT OUTCOMES. WE HAVE 5 AVEA VENTILATORS THAT ARE PROGRAMMED FOR VOLUME GUARANTEE. TWO OF THE SERIAL NUMBERS THAT YOU REQUESTED ARE AS FOLLOWS: (B)(4). I APPRECIATE YOUR TIME IN ASSISTING US WITH OUR VENTILATION CONCERNS." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM AN E-MAIL RECEIVED FROM THE USER FACILITY ON (B)(6) 2013, THAT WAS IN RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADDITIONAL INFORMATION. "I RECENTLY RECEIVED INFORMATION FROM OUR ATTENDING IN THE FORM OF A POWERPOINT PRESENTATION THAT DOES NOT INCLUDE PT NAMES. THERE WERE FOUR INSTANCES OF PIE, TWO OF WHICH EXPIRED. ALL FOUR CASES OF PIE WERE TRANSFERRED OUT OF OUR HOSPITAL, AND WE WERE LATER NOTIFIED OF THE TWO THAT EXPIRED AT THE OTHER FACILITY. I DO NOT HAVE THE ACTUAL VENTS THAT THE PT'S WERE ON, THAT WOULD TAKE SOME MORE INVESTIGATING, BUT COULD BE RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191106 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU