Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy

Mark D. Gershman, Donald J. Kennedy, Judith Noble-Wang, Curi Kim, Jessica Gullion, Marilyn Kacica, Bette Jensen, Neil Pascoe, Lisa Saiman, Jean McHale, Melinda Wilkins, Dianna Schoonmaker-Bopp, Joshua Clayton, Matthew Arduino, Arjun Srinivasan

Research output: Contribution to journalArticlepeer-review

103 Scopus citations

Abstract

Background. Pharmaceutical compounding, the manipulation of ingredients to create a customized medication, is a widespread practice. In January 2005, the Centers for Disease Control and Prevention was notified of 4 cases of Pseudomonas fluorescens bacteremia that were traced to contaminated heparinized saline intravenous flush syringes prepared as a compounded medical product. Patients and Methods. We reviewed medical records of symptomatic patients with P. fluorescens-positive cultures of blood specimens or sections of explanted catheters, reviewed the production process of syringes, performed syringe cultures, compared isolates by pulsed-field gel electrophoresis (PFGE), and examined catheters by scanning electron microscopy. Results. We identified 80 patients in 6 states with P. fluorescens-positive cultures during December 2004-March 2006. Sixty-four patients (80%) had received a diagnosis of cancer. Seventy-four (99%) of 75 patients for whom information about catheter type was available had long-term indwelling catheters. Thirty-three (41%) of 80 cases were diagnosed 84-421 days after the patient's last potential exposure to a contaminated flush (delayed-onset cases). Compared with patients with early infection onset, more patients with delayed infection onset had venous ports (100% versus 50%; ). By P < .001 PFGE, clinical isolates from 50 (98%) of 51 patients were related to isolates cultured from unopened syringes. Scanning electron microscopy of explanted catheters revealed biofilms containing organisms morphologically consistent with P. fluorescens. Conclusion. This outbreak underscores important challenges in ensuring the safety of compounded pharmaceuticals and demonstrates the potential for substantially delayed infections after exposures to contaminated infusates. Exposures to compounded products should be considered when investigating outbreaks. Patients exposed to contaminated infusates require careful follow-up, because infections can occur long after exposure.

Original languageEnglish (US)
Pages (from-to)1372-1379
Number of pages8
JournalClinical Infectious Diseases
Volume47
Issue number11
DOIs
StatePublished - Dec 1 2008
Externally publishedYes

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