BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYCO HEALTHCARE/NELLCOR

    MDR report key: 547445 · Received September 15, 2004

    Report

    Report Number
    547445
    Event Type
    Injury
    Date Received
    September 15, 2004
    Date of Event
    August 24, 2004
    Report Date
    September 3, 2004
    Manufacturer
    TYCO HEALTHCARE / NELLCOR
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ENROLLED IN AN APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B. CEPACIA AND S. MALTOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUELAE.

    Description of Event or Problem · 2

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR S. MATOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALAE.

    Description of Event or Problem · 3

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASURMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA AND S. MALTOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALE.

    Description of Event or Problem · 4

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALE.

    Description of Event or Problem · 5

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALE.

    Description of Event or Problem · 6

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPIA AND S. MALTOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALAE.

    Description of Event or Problem · 7

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALAE.

    Description of Event or Problem · 8

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THE PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA AND S. MALTOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALAE.

    Description of Event or Problem · 9

    PT WAS ENROLLED IN AN IRB APPROVED STUDY UTILIZING SUBLINGUAL CO2 MEASUREMENTS TO EVALUATE TISSUE PERFUSION FOLLOWING CARDIAC SURGERY. THIS PT DEVELOPED POSITIVE ENDOTRACHEAL TUBE CULTURES FOR B CEPACIA AND S. MALTOPHILIA. WHEN THE CO2 PROBE WAS SUSPECTED AS A SOURCE OF INFECTION, STUDY WAS HALTED. PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH NO SEQUALAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE/NELLCOR CAPNOPROBE SUBLINGUAL SENSOR CCK TYCO HEALTHCARE / NELLCOR SLS1 *
    2 TYCO HEALTHCARE / NELLCOR COPNOPROBE SUBLINGUAL SENSOR CCK TYCO HEALTHCARE / NELLCOR SLS1 SS04121096
    3 TYCO HEALTHCARE/NELLCOR CAPNOPROBE SUBLINGUAL SENSOR CCK TYCO HEALTHCARE / NELLCOR SLS1 SS00312901

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    2 1 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    3 1 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    4 2 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    5 2 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBLE SL.
    6 1 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    7 1 MO Hospitalization NELLCO MODEL N-80 CAPNO PROBE SL.
    8 2 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.
    9 2 MO Hospitalization NELLCOR MODEL N-80 CAPNO PROBE SL.