A year ago, there was a shortage of large volume (1000mL) IV solutions that included 0.9% NaCL and other IV fluids. Read my blog post here.
This year isn’t any better. A new set of issues related to IV saline solution and other IV fluids have surfaced.
1. Simulated Saline IV fluids were mistakenly given to patients. These were unsterilized IV fluids meant for training but were released for patient use. The simulated IV saline bags were from Wallcur. According to the FDA, more than 40 individuals who received infusions of the simulated Practi-0.9% sodium chloride IV products; 26 of whom reported adverse events that ranged from flu-like symptoms to sepsis, a potentially life-threatening complication of an infection. Of those 26 individuals, 2 deaths and 11 hospitalizations were reported. The FDA has investigated this incident. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas spp., Rhizobium radiobacter, Sphingomonas koreensis, Sphingomonas trueperi, Sphingobium sp.). It is possible that additional bacteria are present in other bags that were not included in this analysis.
So what can healthcare professionals do? The FDA recommends the following:
- Visually inspect all current IV solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% sodium chloride,” or “For clinical training purposes only”;
- Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for patient use;
- Seek medical attention if you were given a simulated Practi-0.9% sodium chloride product and you experience the symptoms described above;
- Report any suspected adverse events associated with accidental or intentional exposure to simulated products to FDA’s MedWatch program
2. Baxter Initiates Voluntary Recall of Select Lots of IV Solutions Due to the Potential Presence of Particulate Matter. Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.
The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015. While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter. Baxter began the customer notification process on March 24, 2015. The lot numbers affected are listed here – http://www.fda.gov/Safety/Recalls/ucm442074.htm
So what can healthcare professionals do?
- Customers have been directed not to use products from the recalled lots.
- Recalled products should be returned to Baxter
- Unaffected lots of product are available for replacement.
- Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program
It’s just hard to think that IV saline solution is in short supply.Not having IV Saline solution available is like not having bread and milk at the grocery stores!! But now more than ever, we need to be more vigilant in inspecting the IV bags, checking and double checking the bag labels, and be knowledgeable about recalls and safety alerts. Often nurses think this is a pharmacy problem, not ours. But it is, it is everyone’s problem.