Multistate Outbreak of Burkholderia cepacia Bloodstream Infections Associated with Contaminated Prefilled Saline Flush Syringes

See also : B. cepacia Docusate Outbreak

Background

Burkholderia cepacia (B. cepacia) is a group or “complex” of bacteria that can be found in soil and water. On September 23, 2016, the Maryland Department of Health and Mental Hygiene alerted CDC to a cluster of B. cepacia bloodstream infections in a rehabilitation facility. Four additional states were subsequently identified as having clusters of B. cepacia infections among residents of long-term care or rehabilitation facilities. Infections were identified among persons who were receiving intravenous (IV) fluids and/or antibiotics through central venous catheters. CDC assisted with the investigation of this outbreak, working closely with the U.S. Food & Drug Administration, the Delaware Health and Social Services, the Maryland Department of Health and Mental Hygiene, the New Jersey Department of Health, the New York State Department of Health, and the Pennsylvania Department of Health.

Results

Contaminated prefilled saline flush syringes manufactured by Nurse Assist, Haltom City, TX, were identified as the source of the outbreak. Nurse Assist performed a voluntary recall and removal of all its prefilled saline flush syringes on October 4, 2016. Facilities that received flush syringes from the contaminated lot were notified and directed to search for and sequester the product to prevent additional residents from being exposed. As of January 11, 2017, 164 cases from 59 facilities were identified, as detailed in the following table.

*Blood culture yielding B. cepacia in a patient who received intravenous care at a facility that was utilizing prefilled 0.9% sodium chloride IV flush solution manufactured by Nurse Assist.
**It has not been determined whether the deaths associated with this outbreak were caused by the B. cepacia infection, the patients’ underlying health conditions, or another cause

CURRENT AS OF April 19, 2017. 

Actions

Public health authorities coordinated efforts and expertise of epidemiologists and laboratory staff from CDC, FDA, many state and local health departments, as well as hospitals and reference laboratories to obtain and manage data, perform cultures and molecular testing, share results and information, and communicate with healthcare providers and the public.  Public awareness was heightened through communication efforts utilizing this CDC website that summarized key findings and provided frequent updates during the outbreak investigation. This swift action lead to identifying the source of the outbreak and preventing further cases.

Recommendations

Distributors, healthcare facilities and healthcare providers were advised to:

• Stop using any remaining recalled Nurse Assist prefilled saline flush syringe products.
• Immediately recover any unused product from pharmacies, medication carts, medication preparation areas, and patient care areas. Sequester these products in such a way that they are secured and not prone to further distribution or use within the facility.
• Notify local or state health authorities of any cases of B. cepacia bloodstream infections identified among patients who received intravenous care at a facility that was using these products and whose symptoms began since August 1, 2016.
• Report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Additional Information for patients and their healthcare providers

• Saline flush is administered into a vein through an IV. Therefore, the B. cepacia infections seen in this outbreak were bloodstream infections.
• Common symptoms seen with bloodstream infections include:
  • Fever
  • Chills or shivering
  • Clammy or sweaty skin
  • Confusion or disorientation
  • Shortness of breath
  • Increased heart rate
• B. cepacia can be resistant to many common antibiotics. Decisions on the treatment of B. cepacia infections should be made on a case-by-case basis.