BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 2555074 · Received April 27, 2012

    Report

    Report Number
    2021710-2012-00041
    Event Type
    Death
    Date Received
    April 27, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, CAREFUSION SENT A LETTER VIA E-MAIL TO CAREFUSION (B)(4) WHO THEN FORWARDED TO THE FOREIGN DISTRIBUTOR SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF (B)(4) 2012 THERE HAS BEEN NO RESPONSE FROM THE FOREIGN DISTRIBUTOR. NEITHER THE USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/DISTRIBUTOR REPORT TO THE MANUFACTURER. EVENT WAS DERIVED BASED ON INFORMATION PROVIDED BY CAREFUSION (B)(4). (B)(6). ON (B)(6) 2012 A REPLACEMENT DEVICE (VELA) WAS SENT TO THE FOREIGN DISTRIBUTOR TO REPLACE THE USER FACILITY'S ALLEGED FAULTY DEVICE. THE ALLEGED FAULTY DEVICE WAS RECEIVED BY CAREFUSION ON (B)(4) 2012, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CAREFUSION (B)(4) BY THE USER FACILITY IN (B)(6) AND RELAYED TO CAREFUSION VIA EMAIL AND DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST. "A VITAL ACCIDENT HAPPENED IN [FACILITY NAME REMOVED]: A VELA, INSTALLED IN (B)(6) LAST YEAR, STOPPED SUPPLYING AIR TO THE PATIENT AND ALARMED WHEN IT WAS WORKING TWO WEEKS AGO. ALTHOUGH THE DOCTOR CHANGED ANOTHER BREATHING MACHINE RIGHT AWAY, THE DEATH OF THE PATIENT COULDN'T BE AVOIDED. THE BROKEN-DOWN VELA WAS CHECKED AFTERWARDS AND THE MAIN BOARD WAS FOUND BROKEN AND NEEDS CHANGING. THE PATIENT HAS BEEN IDENTIFIED AS A (B)(6) FEMALE BEING TREATED VIA INVASIVE MODES OF VENTILATION. DURING A CONVERSATION WITH THE FACILITY, THE CAREFUSION CUSTOMER SUPPORT MANAGER IN (B)(4) WAS ABLE TO IDENTIFY THAT THIS VENTILATOR WAS ALLOWED TO OPERATE FOR TWO HOURS WITH CONTINUOUS TRANSDUCER FAULT AND TURBINE FAULT ALARMS BEFORE IT WAS REMOVED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR ASKU