According to the FDA, InfuTronix LLC has recalled the Nimbus Administration Set, Flex, and PainPro (also known as the Halo Ambulatory Infusion System), in addition to the Nimbus II PainPRO, Flex, Plus, EpiD, and EMS infusion pumps, due to several potential modes of product failure. Because any of these failures may result in severe injury or death, the recall has been labeled Class I, the most serious type.
Designed to deliver medications and/or fluids to patients under the watch of a doctor or another certified healthcare professional, Nimbus infusion pump systems can be administered under or through the skin (subcutaneous or percutaneous), between the nerves (perineural or epidural), or into blood vessels (intravenous). Patients also sometimes use the pumps to self-administer pain medications, in situations referred to as “patient-controlled analgesia” (PCA). The pump systems can be used in hospital or other healthcare facilities, as well as in patient residences and other nonclinical settings.
The potential failure modes identified by InfuTronix, LLC are as follows: “battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing.”
The use of a pump affected by any of the above failure modes could lead to a range of outcomes:
- infection from microbial contamination after the sterile barrier is lost, as in a leakage
- interrupted or delayed therapy due to unnoticed blockage, which could then result in an under-dosing of critical medications and other fluids, leading to uncontrolled hypertension, as in the case of high blood pressure
- dehydration or an imbalance of electrolytes
- seizures
- shock
- organ failure
- other serious injury
- death
At the time of the FDA update on April 25, 2024, InfuTronix has received 3,698 complaints, six reports of serious injury, and one report of death in connection to the problem.
Healthcare providers who use the Nimbus infusion pump systems are advised of the recall. Patients who are at present receiving infusions through the Nimbus infusion pump systems, or those who might receive other fluids through the pumps, are identified as those potentially impacted.
InfuTronix customers were informed via an Urgent Medical Device Removal letter on February 21, 2024, that after June 20, 2024, all Nimbus infusion pump systems will no longer be available or supported by the company for use. The following actions were recommended:
- Contact InfuTronix customer service at Customerservice@intuvie.com for instructions on the Return Material Authorization (RMA) process in order to have the Nimbus Infusion Pumps and all related infusion sets returned.
- Based on medical expertise of what is appropriate for each patient need, healthcare providers are urged, as soon as possible, to find alternative methods of administering drug product infusions.
Further questions about the recall may be directed to InfuTronix Customer Service by calling (508) 650-2008.
As the FDA continues to monitor this recall, healthcare professionals and consumers alike are asked to report any related adverse reactions or quality issues to the agency’s MedWatch program.
Have you or a family member suffered an adverse health outcome believed to be caused by a defective or mis-used infusion pump system? After a traumatic and potentially life-altering medical event, you deserve justice and financial recourse for the best recovery. Our compassionate attorneys at TruLaw are prepared to help you get compensated for the personal and financial hardships endured, and to hold negligent parties accountable. Contact us online or take our free Instant Case Evaluation ℠ to get started.