BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSESPHOGEAL ECHO

    MDR report key: 758251 · Received June 23, 2006

    Report

    Report Number
    MW1040303
    Event Type
    Other
    Date Received
    June 23, 2006
    Date of Event
    May 30, 2006
    Report Date
    June 23, 2006
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/30, COUNTY ACUTE COMMUNICABLE DISEASE CONTROL WAS INFORMED BY HOSPITAL INFECTION CONTROL PROFESSIONAL OF A CLUSTER OF 8 PATIENTS - OUT OF 19 SURGERIES - WITH E. COLI PNEUMONIA POST CARDIAC SURGERY. ON 5/31, ACDC CONDUCTED MULTIPLE SITE VISITS INCLUDING CHART REVIEW FOR A COHORT STUDY. INVESTIGATION REVEALED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAPH -TEE- USED IN THE SURGERIES OF ALL OF THE CASES WAS DAMAGED. CULTURE OF THE TEE PROBE, RESULTS WERE POSITIVE FOR E. COLI AND KLEBSIELLA. RESULTS SHOW THE E.COLI ISOLATE FROM THE PROBE IS EITHER INDISTINGUISHABLE OR WITH FEW BAND DIFFERENCES TO ALL CASE ISOLATES AND DIFFERENT FROM ALL CONTROL ISOLATES. FOLLOWING THE REMOVAL OF THE DAMAGED TEE, 3 SURGERIES HAVE BEEN, NO NEW CASES IDENTIFIED. DEPT OF HEALTH SERVICES HEALTH FACILITIES OBSERVED AN ELECTIVE SURGICAL PROCEDURE. ONLY DEFICIENCIES WERE IN THE CLEANING AND STORAGE OF THE TEE MACHINE. THE HOSP WILL NOTIFY ACDC IF PNEUMONIA AND/OR SEPSIS OCCURS FROM ANY ORGANISM WITHIN 96 HRS POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSESPHOGEAL ECHO * ITX AGILENT TECHNOLOGIES 21364A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other