IV BOTTLE CONTAMINATION

ABBOTT LABORATORIES

Background of Case Study

By: KHAIRUL ANWAR BIN ROSLI | AN120228

Background of Case Study

• Outbreaks of nosocomial septicemia in many hospitals in America between 1 July 1970 and April 1971.

• Nosocomial septicemia caused by Enterobacter cloacae or E. agglomerans.

• Commonality observed:– All hospital involves used infusion products manufactured by

Abbott Laboratories.– All affected patients had onset of septicemia while receiving the

infusion products from Abbott Laboratories.• Epidemiological and microbiological investigation showed

that the epidemic caused by intrinsic microbial contamination of the IV bottles screw-cap.

• Outcomes of the outbreaks– Contaminated Bottles linked to:

more than 430 Infections 49 death

• Abbott forced to recall 3.5 million bottles of IV fluid• IV sales decreased 84% (from $17.9mil to $3mil)• Abbott redesigns IV bottles seals

Definition of terms:• IV bottles – Intravenous bottles• Nosocomial septicemia – life threatening infection caused by

bacteria acquired or occurring in hospital.• Enterobacter cloacae:

− Gram-negative, facultatively-anaerobic, rod shape bacterium.− Relatively common “ICU bug”− Tends to contaminate various medical, intravenous and other

hospital devices. − also been associated with colonization of certain surgical

equipment and operative cleaning solutions.• E. agglomerans:

− Family of Enterobacteriaceae− Opportunistic pathogen in immunocompromised, causeing

wound, blood and urinary-tract infections.

Enterobacter cloacae on Endo agar with biochemical slope.Sources: http://www.microbiologyinpictures.com/

Intravenous Bottle

References:

1. Mackel D. C. et al., 1975. Nationwide Epidemic of Septicemia Caused by Contaminated Intravenous Products: Mechanisms of Intrinsic Contamination. Journal Of Clinical Microbiology, Dec. 1975, P. 486-497. American Society for Microbiology.