An outbreak of neonatal deaths in Brazil associated with contaminated intravenous fluids.
A nursery outbreak of fever and clinical sepsis resulted in the deaths of 36 neonates in Roraima, Brazil. To determine the cause, epidemiologic studies were performed, along with culture and endotoxin analysis of intravenous (iv) fluids. Affected neonates were more likely to have lower birth weight (2.1 vs. 3.2 kg; P<.01), lower APGAR (activity, pulse, grimace, appearance, and respiration) score at 1 (7 vs. 8; P=.1) or 5 min (8 vs. 9; P=.03), lower gestational age (32 vs. 39 weeks; P=.001), or to receive iv medications (20/20 vs. 2/40; P<.0001). Fever occurred only after iv medication administration. Although culture results of unopened iv medications were negative, endotoxin levels of glucose and distilled water for injection were elevated (3.3 and 1.2 U/mL, respectively). Endotoxin-contaminated iv medications were distributed nationally and may have caused other outbreaks of unexplained death. These results highlight the importance of monitoring both pharmaceutical quality and postmarketing surveillance for adverse events.
Garrett
Denise O
DO
Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
McDonald
L Clifford
LC
Wanderley
Ailton
A
Wanderley
Celeste
C
Miller
Phyllis
P
Carr
Janice
J
Arduino
Matthew
M
Sehulster
Lynne
L
Anderson
Roger
R
Jarvis
William R
WR
D001724:Birth Weight; D001938:Brazil / Q000453:epidemiology; D016022:Case-Control Studies; D015331:Cohort Studies; D004196:Disease Outbreaks; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis; D005260:Female; D005334:Fever / Q000453:epidemiology* / Q000209:etiology; D005440:Fluid Therapy / Q000009:adverse effects; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D007262:Infusions, Intravenous; D008297:Male; D009725:Nurseries, Hospital; D010288:Parenteral Nutrition; D012307:Risk Factors; D018805:Sepsis / Q000453:epidemiology* / Q000209:etiology
D004731:Endotoxins