Skip Navigation LinksHRCAlerts012115_Manufacturer

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention are continuing to investigate a series of instances in which patients were accidentally infused with nonsterile simulated intravenous (IV) saline that was only intended for training purposes, according to a January 14, 2015, FDA statement. The saline in question, Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states. FDA has received more than 40 reports of patients who were injected with the simulated saline, many of whom experienced adverse reactions, including fever, chills, tremors, headache, and possibly death. Wallcur has initiated a voluntary recall of the simulated products, and FDA is working with distributors to determine how they entered the supply chain in the first place. FDA is asking clinicians and office staff to take steps to ensure that IV solution simulation products are removed from facilities' inventories to eliminate the possibility of their use, including visually inspecting all current IV saline solution bags to ensure that none are labeled "Wallcur," "Practi-products," "For clinical simulation," or "Not for use in human or animal patients." If providers suspect that simulated IV products have been used on a patient, they should report the incident to their state health department, whether or not it resulted in an adverse event. FDA will continue to investigate the issue and provide updates as needed.

 

HRC Recommends: Labels on medications, bags, or other items for medical use can often be similar, resulting in confusion and the potential misadministration of a medication or other product, such as in the cases above. Organizations should review their policies regarding item identification, labeling, and differentiation. Tools such as the Institute for Safe Medication Practice's tall-man lettering system or a bar-coded medication system can reduce the likelihood that incorrect products will be administered to patients.

Topics and Metadata

Topics

Infusion Therapy; Medication/Drug Safety; Pharmacy; Supply Chain Management

Caresetting

Hospital Inpatient; Hospital Outpatient

Clinical Specialty

Critical Care; Emergency Medicine; Hospital Medicine; Nursing; Pain Management; Pharmacology

Roles

Clinical Practitioner; Materials Manager/Procurement Manager; Nurse; Patient Safety Officer; Pharmacist; Quality Assurance Manager; Risk Manager

Information Type

News

Phase of Diffusion

 

Technology Class

 

Clinical Category

 

UMDNS

SourceBase Supplier

Product Catalog

MeSH

ICD 9/ICD 10

FDA SPN

SNOMED

HCPCS

Disease/Condition

 

Publication History

​Published January 21, 2015

Who Should Read This

​Materials management, Patient safety officer, Pharmacy, Quality improvement