BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 3201760 · Received July 2, 2013

    Report

    Report Number
    2031702-2013-00150
    Event Type
    Death
    Date Received
    July 2, 2013
    Date of Event
    June 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALARM CODES FOUND IN THE EVENT TRACE ALL FALL INTO WHAT ARE CONSIDERED NON-CRITICAL ALARMS. THESE ALARMS ARE CONSIDERED TO BE TYPICAL ALARMS THAT NORMALLY OCCUR DURING PATIENT VENTILATION. THE INCIDENCE COUNTS FOR THESE ALARMS APPEAR TO BE CONSISTENT WITH THE USAGE TIME FOR THE PARTICULAR POWER-ON/POWER-OFF SEQUENCE. THE DATE OF THE REPORTED INCIDENT WAS IN THE OVERNIGHT HOURS BETWEEN (B)(6) 2013. THE EVENT TRACE INDICATES THIS OPERATIONAL PERIOD STARTED ON (B)(6) 2013, AT 07:16 PM AND ENDED ON (B)(6) 2013, AT 06:13 AM. THE EVENT TRACE REVEALED THE VENTILATOR ISSUED A LOW MINUTE VOLUME ALARM CONDITION 69 SECONDS PRIOR TO BEING PROPERLY POWERED DOWN. THIS ENTRY HAS NO ASSOCIATED ALARM CLEAR ENTRY. THE VENTILATOR ISSUED A LOW PRESSURE ALARM CONDITION 12 SECONDS PRIOR TO BEING PROPERLY POWERED DOWN. THIS ENTRY HAS NO ASSOCIATED ALARM CLEAR ENTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THE PATIENT¿S DAD FELT THAT THE VENTILATOR WAS NOT DELIVERING ANY KIND OF BREATH. WHEN THE VENTILATOR WAS PLACED ON A TEST LUNG, THE LUNG WAS NOT INFLATING AND WAS SHOWING SIGNS OF A LEAK. HE STATED THE WATER TRAP ON THE CIRCUIT WAS INCORRECTLY THREADED/ASSEMBLED. THE VENTILATOR HAD LOW MIN VOLUME ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301851 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 Death