BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 2570786 · Received May 3, 2012

    Report

    Report Number
    2021710-2012-00045
    Event Type
    Death
    Date Received
    May 3, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT ALLEGE ANY FAILURE OF THE UNIT TO OPERATE AS INTENDED WHILE ON THE PT. ON (B)(4) 2012, CAREFUSION SENT A LETTER VIA E-MAIL TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT INCLUDING THE PRIMARY AND SECONDARY CAUSES OF DEATH OF THE PT AND A DETERMINATION IF THE REPORTED FAILURE CAUSED OR CONTRIBUTED TO THE DEATH. AS OF (B)(4) 2012, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE WAS A FAULTY POWER SUPPLY ASSEMBLY. CAREFUSION HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST TO FURTHER INVESTIGATE THIS ISSUE. THE USER FACILITY WAS SHIPPED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012, BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "CUSTOMER CLAIMS THIS UNIT IS HAVING ISSUES WITH THE BATTERY AGAIN, UNIT IS NOT RUNNING ON BATTERY, AND THE 5AMP FUSE IS BURNED AGAIN. DC STATUS INDICATOR IS CHANGING COLORS FROM RED TO YELLOW. THIS UNIT WAS ON A PT AND CONNECTED TO AC. BIOMED CLAIMS THE PT DIED; SHE WAS VERY ILL AND WAS EXPECTED TO DIE. A SERVICE CALL WAS DISPATCH RECENTLY FOR THE SAME ISSUE, NOT RUNNING ON BATTERY, (B)(4). CUSTOMER WANTS THIS PROBLEM SOLVED, HE IS NOT GOING TO PUT THIS UNIT ON SERVICE UNTIL WE CORRECT THE ISSUE."

    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 Death