BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 2134984 · Received June 15, 2011

    Report

    Report Number
    2021710-2011-00038
    Event Type
    Death
    Date Received
    June 15, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION SENT TWO LETTERS VIA E-MAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE PRIMARY AND SECONDARY CAUSES OF THE PT'S DEATH. AS OF (B)(4), 2011, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE AND INFORMATION THAT WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP IN RESPONSE TO A FACE TO FACE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B)(4): THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THUS NO ROOT CAUSE WAS DETERMINED. THE CAREFUSION FIELD SERVICE REP RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER'S CONTROL READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY VERIFIED LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    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 REPRESENTATIVE. "CUSTOMER CLAIMS THIS UNIT HAS AN ALARM RELATED TO "PEEP" HE HAS NO MORE INFORMATION ON THIS ISSUE, I ASKED THE CUSTOMER IF THE PEEP ALARMS ARE SET CORRECTLY OR IF THE PT CIRCUIT CAME OFF THE PT? HE DOES NOT HAVE THIS INFORMATION. CUSTOMER WANTS FIELD SERVICE TO COME IN AND CORRECT THIS PROBLEM." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REP. "[NAME REMOVED} CALLED AND STATED THIS VENT WAS ON A PT THAT DIED. HE IS COLLECTING MORE INFO ON THE INCIDENT. HE WAS ON SITE AND WILL FOLLOW UP AFTER HE FINISHES THE CALL." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP. IN RESPONSE TO A FACE TO FACE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "RT'S CALLED ABOUT LOW PEEP ALARM AROUND 10:40, CODE CALLED AT 11:38." "WHILE TRYING TO ELIMINATE A LOW PEEP ALARM ,STAFF CHANGED VENT FROM: SIMV SETTINGS: RATE: 10 BPM, VOLUME: .5L, PRESSURE SUPPORT: 14 CMH20, PEEP: 5 CMH20. TO A/C SETTINGS: RATE: 10 BPM, VOLUME: .5 L, PEEP: 5 CMH20. ALARMS WERE REPORTEDLY SET AS FOLLOWS: ALARM: HI RATE: 40BPM, LOW VTE: .2 L, HIGH VTE: 2 L, LOW VE: 3, HIGH VE: 45, LOW PPEEK: 5, HIGH PPEEK: 60, LOW PEEP: 2, APNEA: 20. THE CODE STARTED AT 1148PM, ENDED AT 1230 AM, PT DECLARED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU