BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 3068060 · Received April 9, 2013

    Report

    Report Number
    2021710-2013-00020
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT ALLEGE ANY FAILURE OF THE UNIT TO OPERATE AS INTENDED WHILE ON THE PATIENT. ON (B)(4) 2013, CAREFUSION SENT AN E-MAIL TO THE DISTRIBUTOR SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT INCLUDING THE PRIMARY AND SECONDARY CAUSES OF DEATH OF THE PATIENT AND A DETERMINATION IF THE REPORTED FAILURE CAUSED OR CONTRIBUTED TO THE DEATH. AS OF (B)(4) 2013, THERE HAS BEEN NO RESPONSE FROM THE DISTRIBUTOR. NEITHER THE USE FACILITY NOR THE DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE DISTRIBUTOR. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE CARDINAL HEALTH OWNED RENTAL DEVICE IS A SUMMARY OF THE INFORMATION PROVIDED BY THE DISTRIBUTOR (B)(4) VIA E-MAIL. THE DISTRIBUTOR (B)(4) EVALUATED THE DEVICE AND WAS NOT ABLE TO IDENTIFY ANY ANOMALIES OR PERFORMANCE RELATED CONCERNS WITH THE DEVICE. AS A PRECAUTION THE DEVICE WAS REMOVED FROM THE USER FACILITY AND TRANSFERRED TO THE DISTRIBUTOR CARDINAL HEALTH. PER INFORMATION PROVIDED BY THE USER FACILITY TO A CAREFUSION SALES REPRESENTATIVE, THE USER FACILITY DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. BASED ON THE AVAILABLE INFORMATION, CAREFUSION HAS CONCLUDED THAT THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. IF MATERIAL OR ADDITIONAL INFORMATION SHOULD BE MADE AVAILABLE FOR INVESTIGATION, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM AN E-MAIL RECEIVED FROM THE DISTRIBUTOR (B)(6) 2013. "(B)(6) 4PM- BIOMED CALLED (B)(6) PM TO NOTIFY THAT ON TUESDAY OR WEDNESDAY THAT THERE WAS A PATIENT EVENT WITH DEATH CONSEQUENCES WITH AVEA ON LOANER (SN (B)(4), 8,048HRS, SOFTWARE VERSION 4.4). PATIENT FAMILY ALLEGED RT SUPERVISOR THAT THE PROBLEM WAS WITH THE VENTILATOR, BUT (B)(4) BIOMED CONFIRMED WITH RT DEPARTMENT THAT ISSUE WAS NOT RELATED TO VENTILATOR PERFORMANCE. THIS INFORMATION WAS REFERRED TO (B)(6) ON THE CALL. UNIT WAS REMOVED IMMEDIATELY TO BIOMED DEPARTMENT. FRIDAY (B)(6)- CARDINAL BIOMED (B)(4) VISITED BIOMED DEPARTMENT TO RUN TESTS: PERFORMANCE VERIFICATION TEST (VOLUME, PRESSURE, FLOW O2 CONCENTRATION, VALIDATION THAT PM WAS UP TO DATE). UNIT WAS REMOVED FROM THE ACCOUNT AND TRANSFERRED TO OUR SERVICE DEPARTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148061 CAREFUSION CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU/ASKU