The Unusual Outbreak of Sepsis in a Cancer Hospital Caused by Intrinsically Contaminated Heparin Injection Vials

Bajpai, Vijeta; Kapoor, Akhil; Mishra, Anwita; Sansar, Bipinesh; Gupta, Anuj; Sarode, Rahul; Kirtaniya, Jyotirmay; Angrup, Archana; Biswal, Manisha; Mishra, Bal Krishna

doi:10.31557/APJCP.2026.27.10.3629

The Unusual Outbreak of Sepsis in a Cancer Hospital Caused by Intrinsically Contaminated Heparin Injection Vials

Document Type : Research Articles

Authors

¹ Department of Microbiology, MPMMCC, Varanasi (HBNI Mumbai), India.

² Department of Medical oncology, MPMMCC/HBCH, Varanasi (HBNI Mumbai), India.

³ Department of Microbiology, MPMMCC/HBCH, Varanasi (HBNI Mumbai), India.

⁴ Department of Critical Care, MPMMCC/HBCH, Varanasi. (HBNI Mumbai), India.

⁵ Department of Medical Microbiology, PGI, Chandigarh, India.

10.31557/APJCP.2026.27.10.3629

Abstract

Background: The outbreaks in oncology settings result in dreaded complications, especially in cancer patients who are already immunocompromised. Here, we describe the identification and response to an unusual hospital-acquired outbreak of bloodstream infections (BSIs) in cancer patients due to intrinsic contamination of a heparin injection vial with New Delhi metallo-beta-lactamase (blaNDM)-positive Klebsiella pneumoniae. Methods: An increased cluster of sepsis cases in cancer patients with chemoports was noted in the medical oncology department of a cancer center in North India in July 2024. These case clusters were identified by reviewing microbiological reports, and blood cultures were tested by automated identification and susceptibility testing, the Carba-R test, and molecular testing. Outbreak investigations were performed; causality assessment was also done. The clinical and demographic details of the case patients, along with other relevant histories, were collected from electronic medical records. Environmental samples were collected from high-touch surfaces, intravenous medications, saline, and heparin. Results: A cluster of 10 sepsis cases with culture-confirmed bloodstream infections (BSIs) was identified in the medical oncology department. Out of the 10 patients, 5 (50%) were admitted to the ward after visiting the central venous access device (CVAD) clinic, and 5 (50%) presented to the emergency department after recent chemotherapy. All cases had Klebsiella pneumoniae isolated from blood cultures, which alerted the oncology team to a possible outbreak. All isolates were multidrug-resistant strains sensitive to ceftazidime-avibactam and tigecycline. The multidrug resistance gene detected in all isolates was blaNDM. The heparin injection vial was found to be the primary cause and single source of the outbreak. All isolates from heparin and patients’ clinical samples were confirmed by molecular typing using Enterobacterial Repetitive Intergenic Consensus Polymerase Chain Reaction (ERIC-PCR). Interestingly, the contamination was found to be intrinsic to a new batch of heparin manufactured by the company. Conclusion: This study highlights the importance of an infection surveillance system as part of pharmacovigilance, which helped detect the source of infection within a few days of the outbreak alert. Implementing standardized healthcare-associated infection (HAI) surveillance in a low-resource setting detected an ongoing heparin-associated outbreak. The outbreak investigation and the use of a multimodal approach reduced incident cases and informed changes in infection prevention and control (IPC) practices. The regulatory authorities (CDSCO and the Indian Pharmacopoeia Commission) were also notified, which helped them enforce strict quality control and regulatory oversight in drug manufacturing.

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