InfuTronix Recalls 52,328 Infusion Pump Systems Due to Multiple Potential Failure Modes

May 2, 2024
The company reported that there were six serious injuries, and one death related to this issue.

According to an April 25 announcement, InfuTronix is recalling 52,328 infusion pump systems, the Nimbus and Nimbus II Infusion Pump Systems

The Nimbus Administration Set, Flex, and PainPro, also known as the Halo Ambulatory Infusion System, as well as the Nimbus II PainPRO, Flex, Plus, EpiD, and EMS infusion pumps (Nimbus infusion pump systems) are intended to deliver medications and/or fluids to a patient under the direction or supervision of a doctor or other certified health care professional. These devices are used for infusions under or through the skin (subcutaneous or percutaneous), in the spaces between nerves (perineural or epidural), or into blood vessels (intravenous). The pumps are sometimes also used for patients to deliver their own pain medications (patient-controlled analgesia, or PCA).

Nimbus infusion pump systems are used in hospitals, other healthcare facilities, and in nonclinical environments such as patient homes.

InfuTronix, LLC is recalling Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. The devices will not be available or supported after June 20, 2024.

Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage), interruptions or delays in therapy from unnoticed occlusion may lead to underdosing of vital medications and fluids resulting in uncontrolled hypertension (high blood pressure), dehydration (water loss), and electrolyte imbalance; seizures, shock and organ failure may occur. Use of these products may lead to serious injury or death.

InfuTronix reports 3,698 complaints, six serious injuries, and one death related to this issue.