In recent years, the healthcare industry has witnessed a concerning trend with a significant increase in the number of infusion device recalls. These recalls, which involve critical medical devices used to administer fluids, medication, and vital treatments, have raised serious concerns about patient safety and the effectiveness of regulatory oversight. From major manufacturers to established healthcare providers, a series of recalls have highlighted the vulnerabilities and potential risks associated with infusion pumps, placing a spotlight on the need for enhanced safety measures and stricter quality control protocols.
The recall notices issued by prominent companies such as Smiths Medical, ICU Medical, Intera Oncology, Baxter, Fresenius Kabi, and Insulet have captured attention due to their classification as Class I recalls—the most severe category designated by regulatory bodies like the U.S. Food and Drug Administration (FDA). These recalls indicate that the use of these devices poses a significant risk of causing serious harm or even death to patients.
The infusion devices subject to recall have exhibited a range of issues, including false alarms, unanticipated depleted battery alarms, abnormal circuit board behavior, and failure of critical system components. Furthermore, some devices have experienced malfunctioning communication networks, interruptions in medication delivery, and inaccurate displays of critical dosage information. These flaws can compromise the reliable and accurate administration of life-sustaining medications, posing an immediate threat to patients who rely on these devices for their care. These recalls include:
Smiths Medical Infusion Pumps
The FDA has issued a Class I recall notice for infusion pumps manufactured by Smiths Medical due to multiple potential issues. The company has recalled 118,055 devices in the US, with seven reports of serious injury and one death associated with the recalled pumps. Smiths Medical intends to address the issues through upcoming software releases.
Smiths Medical Medfusion 3500 and 4000
Smiths Medical has issued an urgent field safety notice in Europe for its Medfusion 3500 and 4000 infusion pumps, warning about eight potential issues. The issues include false alarms, battery depletion, abnormal circuit board behavior, and network configuration problems. The company has received reports of serious injuries and one death related to three of the identified issues.
Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump has been classified as a Class I recall by the FDA. The recall was initiated due to reports of the pumps delivering medication at faster than expected flow rates, which can lead to serious toxicity or death. There have been no reports of injuries or deaths associated with the recalled devices.
Plum Infusion Devices
ICU Medical’s recall of replacement batteries for certain infusion systems, including the Plum 360, Plum A+, and Plum A+3, has been classified as a Class I recall by the FDA. The recall was initiated due to a manufacturing defect that affects the battery life of the devices. While there have been no reports of injuries or deaths, the issue could potentially cause interruptions or delays in critical fluid delivery.
Sigma Spectrum Infusion Pumps
Baxter has issued an urgent device correction for its Sigma Spectrum infusion pumps due to improper cleaning that can cause battery corrosion. The FDA has classified the recall as Class I, with 16 reports of serious injuries associated with the problem. Baxter recommends adhering to cleaning instructions, monitoring the battery status, and having backup devices available.
Spectrum IQ Infusion Pumps and Dose IQ Safety Software
Baxter has issued an urgent medical device correction for its Spectrum IQ infusion pumps, following a Class I recall of its Dose IQ safety software program. The recall was initiated due to a software defect that may lead to mismatched drug information in drug libraries. While there have been no reports of adverse events or patient injury, certain factors resulting from the issue could have serious consequences. Baxter is developing a software upgrade to address the problem.
Ivenix Infusion Systems
Fresenius Kabi has issued a Class I recall for some Ivenix infusion systems due to a leak that can damage the electrical system and result in a loss of power. This can lead to interruptions or delays in critical fluid delivery, potentially causing serious injury or death. There have been 14 complaints related to this issue, but no reported injuries or deaths.
Insulet Omnipod Dash Batteries
The FDA has classified the recall of Insulet’s Omnipod Dash batteries as Class I. Insulet issued a voluntary global safety notice warning about battery problems. The Omnipod Dash is a previous-generation insulin pump, and the company has received 455 complaints, including reports of fires. No injuries or deaths have been reported.
The scale of the recalls is deeply concerning. These recalls underline the urgent need for improved manufacturing standards, comprehensive device testing, and rigorous post-market surveillance to prevent potential harm to patients.
As the healthcare industry continues to rely heavily on infusion devices for delivering critical medications and treatments, it is imperative to address the root causes behind these alarming recalls. This article examines the recent surge in infusion device recalls, analyzes the common issues reported, explores their potential impact on patient safety, and discusses the necessary measures that should be taken by manufacturers, regulators, and healthcare providers to ensure the reliability and integrity of these vital medical devices.
If you or a loved one has been seriously injured due to an infusion pump malfunction, we want to help. Contact our dangerous medical device team at OnderLaw at 800-799-2824 for a free, no-obligation consultation. We’re changing the way corporations do business, and we will stand with you.