FDA Adverse Event Malfunction Summary report: N

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MDR report key: 964882 · Received November 23, 2007

Report

Report Number
964882
Event Type
Malfunction
Date Received
November 23, 2007
Date of Event
July 31, 2007
Report Date
November 19, 2007
Manufacturer
FUJINON, INC.
Product Code
EOQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
GA, US

Narratives

Description of Event or Problem · 1

EPIDEMIOLOGY/INFECTION CONTROL DEPARTMENT BECAME AWARE OF A CLUSTER OF PSEUDOMONAS AERUGINOSA (PA) ISOLATES WITH A UNIQUE ANTIBIOGRAM PATTERN RECOVERED FROM PATIENTS WHO HAD UNDERGONE BRONCHOSCOPY WITH A BAL (BRONCHOALVEOLAR LAVAGE). THE INVESTIGATION DETERMINED THAT THE SOURCE WAS A BRONCHOSCOPE, WHICH WAS FOUND TO BE CULTURE POSITIVE FOR PA DESPITE A NEGATIVE LEAK TEST AND HIGH LEVEL DISINFECTION. BASED ON THESE FINDINGS, THE BRONCHOSCOPE WAS REMOVED FROM SERVICE AND THE OUTBREAK OR PSEUDO-OUTBREAK WAS TERMINATED. THE MANUFACTURER'S EXAM OF THE BRONCHOSCOPE SHOWED INTERNAL DEFECTS. EPIDEMIOLOGY PERFORMED MOLECULAR TYPING STUDIES ON AVAILABLE PA PATIENT ISOLATES AND ON THE PA ISOLATES RECOVERED FROM THE BRONCHOSCOPE. MOLECULAR TYPING STUDIES USING PULSED-FIELD GEL ELECTROPHORESIS SHOWED THAT ALL PA ISOLATES WITH THE PARTICULAR ANTIBIOGRAM PATTERN WERE IDENTICAL, WHICH CONFIRMED THE HYPOTHESIS THAT THE BRONCHOSCOPE WAS THE RESERVOIR FOR P AERUGINOSA. MEDICAL RECORDS OF THE 12 PATIENTS WHO UNDERWENT BRONCHOSCOPY AND HAD A POSITIVE PA HAD NO EVIDENCE OF AN INFECTION DUE TO THIS ORGANISM, AND THAT THE POSITIVE CULTURE APPEARED TO BE DUE TO BAL CULTURES COLLECTED THROUGH THE CONTAMINATED BRONCHOSCOPE (WITH THE EXCEPTION OF THE INDEX CASE WHO WAS THOUGHT TO HAVE A PA PNEUMONIA AT THE TIME OF BRONCHOSCOPY). OF THE CLUSTER CASES STUDIED, TWO PATIENTS MAY HAVE HAD AN ADVERSE OUTCOME ASSOCIATED WITH THE EXPOSURE TO THE CONTAMINATED SCOPE. BOTH PATIENTS DIED, HOWEVER, THESE 2 PATIENTS WERE NOT EXPECTED TO SURVIVE THEIR CURRENT HOSPITAL STAY DUE TO OTHER EXISTING CO-MORBID CONDITIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * BRONCHOSCOPE EOQ FUJINON, INC. EB-270S NA

Patients

Seq Age Sex Outcome Treatment
1 *