BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 3229625 · Received July 8, 2013

    Report

    Report Number
    2021710-2013-00053
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 CAREFUSION SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO ON THE REPORTED EVENT. AS OF (B)(4) 2013 CAREFUSION HAS NOT RECEIVED ANY WRITTEN RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON THE INFO OBTAINED IN THE LETTER FROM THE PT'S LAWYER. (B)(4). DUE TO PENDING LITIGATION THE DEVICE HAS NOT BEEN RELEASED TO CAREFUSION FOR EVAL. CAREFUSION IS IN THE PROCESS OF COORDINATING WITH THE LAWYERS FOR THE PT AND THE USER FACILITY TO BE ON HAND TO OBSERVE ANY EVAL PERFORMED BY A THIRD PARTY ON THE DEVICE. SHOULD CAREFUSION RECEIVE ANY ADDITIONAL INFO REGARDING THE EVENT AND/OR EVAL RESULTS ON THE DEVICE, CAREFUSION WILL SUBMIT A F/U MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE INFO REGARDING THE EVENT IS A SUMMARY OF THE INFO CONTAINED IN A LETTER RECEIVED BY CAREFUSION ON (B)(4) 2013 FROM THE PT'S LAWYER. AN INCIDENT OCCURRED ON (B)(6) 2013 WHERE THE PT WAS SEVERELY INJURED AND ULTIMATELY DIED ON (B)(6) 2013. THE LETTER DID NOT INDICATE THAT THERE WAS ANY DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308602 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU