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Pyrogenic Reactions and Hemorrhage Associated With Intrinsic Exposure to Endotoxin-Contaminated Intravenous Solutions

Published online by Cambridge University Press:  07 April 2017

Luciane Zappelini Daufenbach ,
Waneska A. Alves ,
Jaime B. de Azevedo ,
Matthew J. Arduino ,
Terri S. Forster ,
Eduardo H. Carmo  and
Douglas L. Hatch
Luciane Zappelini Daufenbach*
Affiliation:
Field Epidemiology Training Program, General Coordination of Communicable Diseases, Ministry of Health, Brasília, Recife, Brazil
Waneska A. Alves
Affiliation:
Field Epidemiology Training Program, General Coordination of Communicable Diseases, Ministry of Health, Brasília, Recife, Brazil
Jaime B. de Azevedo
Affiliation:
Department of Sanitary and Epidemiological Surveillance, Recife, Brazil
Matthew J. Arduino
Affiliation:
Environmental and Applied Microbiology Section, Division of Healthcare Quality Promotion, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
Terri S. Forster
Affiliation:
Environmental and Applied Microbiology Section, Division of Healthcare Quality Promotion, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
Eduardo H. Carmo
Affiliation:
Department of Epidemiological Surveillance, General Coordination of Communicable Diseases, Ministry of Health, Brasília, Recife, Brazil
Douglas L. Hatch
Affiliation:
Field Epidemiology Training Program, General Coordination of Communicable Diseases, Ministry of Health, Brasília, Recife, Brazil Division of International Health, Office of Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia
*
Secretaria de Vigilância em Saúde, Esplanada dos Ministérios, Bloco “G”, Edificio Sede, 1° Andar-Ala Norte-Sala 137, Brasília, DF 70058-900, Brazil (luciane.daufenbach@saude.gov.br)
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Abstract

Objective.

An epidemiological investigation was conducted to determine risk factors for adverse reactions among patients in hospitals and the possibility of extrinsic or intrinsic contamination of intravenous solutions.

Design.

A retrospective cohort study was conducted to identify solutions associated with adverse reactions. Implicated lots were cultured for bacteria, and endotoxin concentrations were measured.

Setting.

Five hospitals in the state of Pernambuco, Brazil, were investigated from February through March 2002.

Patients.

Surgical inpatients or outpatients receiving intravenous solutions during the study period.

Results.

Of 355 surgical patients or outpatients treated at hospitals, 28 (8%) developed illness within a mean of 2.5 hours after exposure to intravenous solutions implicated in adverse reactions; 5 (17.9%) of the case patients died. Laboratory testing of bottles from the lots of Ringer's lactate solution implicated in deaths demonstrated a high mean endotoxin concentration of 88.3 endotoxin units (EU)/mL (range, 9.7-298.0 EU/mL), compared with the permitted limit in Brazil of <0.5 EU/mL. Testing of metronidazole implicated in adverse reactions at another hospital and produced by the same company that manufactured the lots Ringer's lactate solution also showed high endotoxin concentrations (mean level, 8.3 EU/mL [range, 5.0-58.3 EU/mL]). The outbreak was controlled after a national recall of the implicated brand of intravenous solutions.

Conclusions.

Case patient status was associated with use of Ringer's lactate solution and metronidazole from large bottles, both of which were produced by the same company. High endotoxin concentrations were demonstrated in unopened bottles of implicated products, which is consistent with intrinsic contamination. The high mortality rate may have been compounded by the fact that clinicians administered additional volumes of contaminated 0.9% isotonic sodium chloride solution in response to hypotension or bleeding to some surgical patients. No additional case patients were identified after a national recall of products, inspection, closure of the implicated company's manufacturing facility, and establishment of random quality-control testing of intravenous solutions.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 27 , Issue 7 , July 2006 , pp. 735 - 741
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2006

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