FDA Issues Multiple Safety Alerts for Medical Devices

fda, medical devices, safety alert

The U.S. Food and Drug Administration (FDA) issues recalls and safety alerts to keep consumers and the healthcare community informed.  Safety alerts often involve drugs, medical devices, supplements and cosmetics.  In September, the FDA issued multiple new safety alerts for medical devices and drugs.  Several of the safety alerts involve product recalls and one relates to cybersecurity.

New Safety Alerts for Medical Devices

At Drug and Device Watch, it is important to us that readers have information about dangerous or defective medical devices.  We want you to be as informed as possible so you can make the best decisions about your healthcare.  Here is an overview of the safety alerts from the FDA in September:

The Metrix Company IV Bags

The Metrix Company is recalling certain lots of empty flexible IV bags.  The recall includes the Metrix Secure EVA Dual Chamber bag and the Baxter ExactaMix bag.  The bags were distributed throughout the United States and Canada between November 2016 and July 2019.

The recall follows several reports of the bags leaking during use.  The bags have the potential to leak around the divider rod, which breaches the sterile barrier.  This can cause infection in the patient.  There are no reports of illness or death, but the FDA warns that healthcare providers should not use these medical devices.

Braun Medical Inc. Infusomat Space Volumetric Infusion Pump Administration Set

Braun Medical Inc. is voluntarily recalling one lot of infusion pumps after receiving numerous complaints about the pumps leaking or disconnecting.  The Infusomat Space Volumetric Infusion Pump Administration Set has a defect in the bonded joint that is between the injection site and the tubing.

The defect can cause two problems:

  • Microorganisms to enter the fluid path and subsequently the circulatory system. Patients who experience contamination are subject to bloodstream infections.
  • Air can enter the tubing and circulatory system leading to air embolization.

The recall includes 2,580 units that were manufactured in September 2018.  They were distributed between November 2018 and March 2019.  The FDA has received 17 complaints about these medical devices. As a result, certified safety alerts are being sent to all affected consumers and healthcare providers.  Patients using these devices should contact their healthcare provider immediately. The FDA warns to discontinue use of these products immediately due to the serious risks.

Mavidon LemonPrep Tubes and Single Use Cups

Mavidon is recalling 21 lots of LemonPrep, a skin preparation lotion used to enhance the signal at electrode sites.  The recall includes both LemonPrep 4 oz.  tubes and LemonPrep single use cups.  Nurses use this product to prep skin for electrodes.  The abrasive quality helps reduce impedance and enhance the quality of the signal.

The products in this recall test positive for Burkholderia cepacia, a drug resistant microorganism.  This pathogenic microorganism can cause serious infection, which may be life-threatening for certain groups.  The FDA warns of possible life-threatening infections among:

  • Cancer patients
  • Pregnant women
  • Elderly
  • Neonates
  • Individuals with compromised immune systems

Currently, the FDA has received one report of adverse events related to the LemonPrep product.  That complaint involves a neonate.  Consequently, the FDA notes that Mavidon is testing other lots to determine if more products may contain Burkholderia cepacia.

Cybersecurity Vulnerabilities Threaten Medical Devices

The FDA reports that there are 11 cybersecurity vulnerabilities currently threatening medical devices.  These vulnerabilities are now called the Urgent/11.  In their safety alert, the FDA warns healthcare providers, patients, facility staff and manufacturers about the possible risks.  The alert says that the vulnerabilities may allow unauthorized sources to remotely access medical devices and:

  • Change function
  • Deny service
  • Leak information
  • Cause defects

The result of tampering with a medical device can be dangerous for the patient.  So far, the FDA has identified the following software and operating systems as having vulnerabilities:

  • VxWorks (by Wind River)
  • Operating System Embedded (OSE) (by ENEA)
  • INTEGRITY (by Green Hills)
  • ThreadX (by Microsoft)
  • ITRON (by TRON Forum)
  • ZebOS (by IP Infusion)

The FDA and manufacturers are warning consumers who use affected medical devices.  There are reports of consumers experiencing problems due to the vulnerabilities. The reports include devices for anesthesia, imaging, and infusions.  Consumers who are affected should contact their healthcare provider to find out if their device is affected.  Also, be on the lookout for communications from manufacturers, who should warn consumers as information is available.  Consumers who believe their device is malfunctioning should get medical help right away.

Hospira, Inc. Bacteriostatic Water

Hospira, Inc.  is recalling a lot of Bacteriostatic water due to some vials not being confirmed as sterile.  The vials in the recall are in 30 mL dose vials.  The product was distributed in the United States and Puerto Rico between March 2018 and April 2018.  Hospira is contacting healthcare providers to arrange for return to these products.

Bacteriostatic water is used to dilute or dissolve certain drugs before administering them intravenously, intramuscularly or subcutaneously.  Administering non-sterile Bacteriostatic water to a patient carries the risk of adverse events including:

  • Invasive bacterial infection
  • Bacterial meningitis
  • Septicemia
  • Cutaneous abscess

Any healthcare provider or facility using these vials should stop immediately and contact the manufacturer.  Patients can also report adverse events through the FDA’s MedWatch Adverse Event Reporting program.

Have Questions about Recalled Medical Devices?

Medical devices are an important part of our healthcare system.  Unfortunately, like any manufactured product, these devices can have defects or be contaminated.  It is the responsibility of manufacturers to check their products and make sure they are safe.  Sometimes manufacturers fail to meet this responsibility and the result is injury to patients.

If you use medical devices at home or routinely as a part of your medical care, you may certainly have questions and concerns about recalls and how they will affect you.  To get answers, contact Drug and Device Watch.  Our team of legal professionals can help you understand medical device recalls and your legal rights as a patient and consumer.

Learn more by calling us at 1-888-458-6825, or by filling out our online contact form.