Contaminated Saline Associated with Death

Medical-grade saline and sterile water products are associated with at least one death, says U.S. Food and Drug Administration (FDA) Adverse Event Report.

Lawsuits likely.

Here’s what we know about the situation.

FDA Receives MedWatch Report Associated with Potentially Contaminated Saline and Sterile Water Products

On November 28, 2023, a MedWatch report was submitted to “Nurse Assist.” According to the notification, “The reporter states that the impacted individual had an ulcer wound that got infected with Candida auris” on November 20, 2023.

The wound was washed daily with water.

White spores (fungal growth) began to appear around the wounds.

According to the report, “the hospital determined that Candida auris got into the blood stream and impacted the individual.”

This bloodstream infection caused septic shock that led to the patient’s death.

Other sources indicate that the sepsis was caused by another pathogen, known as Vibrio.

Both germs can cause blood infections that may result in septic shock and death.

Report Points to Nurse Assist, LLC Contaminated Saline

The MedWatch Report cites a Nurse Assist, LLC manufactured product as the cause of the illness.

The product was 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP BOTTLE.

A recall was issued earlier that month due to sterility concerns with the product.

The Recall

On November 6, 2023, Nurse Assist, LLC issued a recall for their 0.9% Sodium Chloride Irrigation USO and Sterile Water for Irrigation USP.

Routine product testing revealed the potential for a compromised sterile barrier. This prompted further investigations of the issue. As a result, a widened scope for the product recall was included out of an abundance of caution.

This product was shipped throughout the United States and to Canada.

The recall was initiated following concerns of “lack of sterility assurance.” A problem that could result in a nonsterile product.

A huge concern!

The company admits that “in populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in life-threatening adverse events.”

Affected products, potentially also packaged inside kits, were distributed between November 1, 2021 to September 18, 2023.

Products include:

• 9% Sodium Chloride Irrigation USP
  • 100 mL bottles
  • 250 mL bottles
  • 500 mL bottles
  • 1000 mL bottles
  • 1oz spray can
  • 1oz spray can
  • 3 mL syringes
  • 5 mL syringes
  • 10 mL syringes
• Sterile Water for Irrigation USP
  • 100 mL bottles
  • 250 mL bottles
  • 500 mL bottles
  • 1000 mL bottles
  • 120 mL Irrigation USP cups
  • 10 mL syringes
  • 30 mL syringes

All products have expiration dates of November 1, 2023 to September 18, 2025 except part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N). That product has an expiration date range of November 1, 2023 to September 18, 2028.

This product was manufactured by Nurse Assist, LLC, but was also available under many different brand names.

Additional brand names include:

• NURSE ASSIST
• STERICARE
• CARDINAL
• COVIDIEN
• HALYARD OWENS MINOR
• IDEXX
• MAC MEDICAL
• MCKESSON
• MEDICHOICE OWENS MINOR
• MEDLINE
• SOL
• TRUDELL
• VYAIRE

Consumers and healthcare providers who have received these recalled product should stop using them right away.

Major Concerns Associated with Contaminated Saline Include Vibrio Infections and Candida Auris Infections

Lack of sterility can lead to potential contamination with any number of harmful pathogens. The two most probable include Vibrio infections and Candida auris infections. Both can result in life-threatening blood infections leading to septic shock and death.

Vibrio Infections

Vibrio are a type of bacteria responsible for the illness, vibriosis. This can result in an intestinal illness or infected wound. When a wound is infected, it is sometimes referred to as necrotizing fasciitis (though not the only cause of the illness). This is because the flesh around the infected wound dies, appearing like a “flesh-eating bacteria.”

According to the Centers for Disease Control and Prevention (CDC), around 80,000 cases of vibriosis occur in the United States each year. Most of which (52,000 cases) are caused by consuming contaminated food.

Illness is Fast-Acting

The majority of people with Vibrio vulnificus infections require intensive care or even limb amputations. This fast-acting illness claims the lives of 20% of those who become infected. Sometimes in a little as a day or two of becoming ill.

Vibrio Symptoms

Most Vibrio wound infections symptoms include:

• Pain
• Fever
• Swelling
• Warmth
• Redness
• Discharge (leaking fluids)
• Discoloration (turning a color other than normal).

Once in the bloodstream, symptoms may include fever, chills, dangerously low blood pressure, blistering skin lesions. People may die from bloodstream vibriosis.

Candida Auris Infections

Candida auris is a type of yeast often causing infections that are resistant to antifungal treatments.

This yeast is often responsible for invasive infections. However the pathogen can also colonize patients without any signs of infection.

This highly transmissible infection is a type of fungus that can cause life-threatening infections in those who are immunocompromised. Resulting in invasive bloodstream or intra-abdominal infections.

Candida Auris Symptoms

Symptoms of Candida auris infection generally depend on where the infection is in the body.

Common Candida auris infections may include:

• Fever
• Chills
• Low blood pressure
• High heart rate (tachycardia)
• Lethargy (extreme tiredness)
• Low body temperature (hypothermia)

Unfortunately, Candida auris infections in those who are already seriously ill may go unnoticed. Often being masked by other illness symptoms.

In many cases, people may carry Candida auris, but show no signs or symptoms of infection. Despite this lack of true infection, those people may still pass the infection on to someone else.

Have You or a Loved One Been Impacted by This Nurse Alert, LLC Contaminated Saline Recall?

Have you or a loved one been impacted by this Nurse Alert, LLC contaminated saline recall and wish to pursue a legal claim? The Lange Law Firm, PLLC can help.

Consumers put a lot of trust in the products we use. We expect them to be safe, as advertised, and free of harmful effects. When lapses in protocols send potentially harmful products to the market, people get sick. Sometimes people die.

Call (833) 330-3663 or send us an email for a free, no obligation consultation to go over the details of your situation and determine if you have a legal case.

By: Heather Van Tassell (contributing writer, non-lawyer)