BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 4321011 · Received November 24, 2014

    Report

    Report Number
    2021710-2014-00075
    Event Type
    Death
    Date Received
    November 24, 2014
    Report Date
    October 29, 2014
    Manufacturer
    CARFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS ATTEMPTED TO CONTACT THE DOCTOR TO GET FURTHER INFO ABOUT THE REPORTED EVENT AS WELL AS THE DETAILS FOR THE SPECIFIC FAILURE FOR EACH OF THE VENTILATORS BY SERIAL NUMBER. THE DOCTOR INDICATED THAT HE IS UNABLE TO DETERMINE THE SPECIFIC VENTILATOR EACH PT WAS USING AND THAT HE HAS NO AUTHORIZATION FROM HIS ADMINISTRATION TO RELEASE ADDITIONAL INFO AT THIS TIME. THE MEDICAL DEVICE REPORT FOR THE OTHER SUBJECT VENTILATOR IS BEING REPORTED TO MFR REPORT #2021710-2014-00076.

    Description of Event or Problem · 1

    THE DOCTOR AT THE USER FACILITY REPORTED THAT (B)(6) TWINS WERE DELIVERED AT THE FACILITY AND WERE BOTH PLACED ON AVEA VENTILATORS. THE DOCTOR REPORTED THAT DURING PT USE ONE VENTILATOR WAS READING VERY HIGH TIDAL VOLUMES (AROUND 15-20CC/KG). THE DOCTOR REPORTED THAT BOTH PATIENTS DETERIORATED AND THEN SHORTLY THEREAFTER PASSED AWAY. THE REPORTED CAUSE OF DEATH FOR BOTH PATIENTS WAS FRANK PULMONARY HEMORRHAGE. THE DOCTOR PROVIDED THE SERIAL NUMBERS OF THE TWO SUBJECT VENTILATORS BUT DID NOT IDENTIFY THE SPECIFIC FAILURE PER SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761845 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CARFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SURVANTA| ANTIBIOTIC| UMBILICAL LINE