BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIRCUIT VENT VOL F/PORT

    MDR report key: 2172006 · Received April 6, 2006

    Report

    Report Number
    1423507-2006-00042
    Event Type
    Death
    Date Received
    April 6, 2006
    Date of Event
    February 24, 2006
    Report Date
    April 5, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE PRODUCT SAMPLES ARE NOT AVAILABLE FOR EVAL. HOWEVER, SAMPLES FROM OUR CURRENT PROCESS WERE REVIEWED AND NO ANOMALIES WERE FOUND, ALL CONNECTIONS WERE FOUND ACCEPTABLE. OUR MANUFACTURING PROCESS WAS REVIEWED, AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. BASED ON THE INFO RECEIVED THE CIRCUIT DISCONNECTED AT THE HME, WHICH IS NOT PART OF THE CARDINAL HEALTH CIRCUIT. THE HME, THE FLEX TUBE AND THE CLOSED SUCTION SYSTEM WERE ADDED BY THE FACILITY TO THE CARDINAL HEALTH CIRCUIT AND NONE OF THE ADDED DEVICES ARE PRODUCTS PRODUCED BY CARDINAL HEALTH. THE CIRCUIT WAS ALTERED FROM ITS ORIGINAL CONFIGURATION.

    Description of Event or Problem · 1

    THE CIRCUIT WAS BEING USED ON A LONG TERM CARE PT WITH AN ORIGINAL DIAGNOSIS OF A CVA (STROKE). THE CIRCUIT WAS BEING USED WITH A PLV VENTILATOR AND WHILE IN USE ON THE PT THE CIRCUIT BECAME DISCONNECTED AT THE 50CC FLEX TUBE WITH AN HME ATTACHED. THE REPORT WAS THAT 24 CMH2O PRESSURE WAS HELD IN THE CIRCUIT AND THEREFORE THE VENTILATOR DID NOT ALARM FOR LOW VOLUME OR PRESSURE. THE PT MAY HAVE BEEN OFF THE VENTILATOR FOR APPROXIMATELY 30 MINUTES. PT DID PASS AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT VENT VOL F/PORT CIRCUIT VEN /VOL F/PORT BZO CARDINAL HEALTH 001795 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death