Nimbus Infusion Pump Recall Issued After Thousands of Reports Involving Problems That May Cause Medication Errors

InfuTronix, LLC has issued a recall for certain Nimbus infusion pumps due to software and battery problems that could cause medication errors, which have already been reported by thousands of patients.

The U.S. Food and Drug Administration (FDA) announced the Nimbus Infusion Pump recall on March 20, indicating a software and battery defect may cause the pumps to malfunction during administration or turn off the device completely, resulting in either excessive or insufficient delivery of medication, blood, or fluids.

InfuTronix conducted a post-market surveillance system evaluation on Nimbus infusion pumps, which identified several potential issues within the pumps. Subsequently, a health hazard evaluation (HHE) was issued, determining that the failures pose a low risk to consumers.

While no deaths have been reported in relation to the infusion pumps, officials have become aware of at least 3,698 complaints to date, which involved consumers experiencing battery power-off events, upstream occlusion, system errors, drug product egress, discrepancies in flow rate, and pump housing damage.

Nimbus Infusion Pump Recall

Products affected by the recall include the Nimbus Ambulatory Infusion Pump 00817170020000, Nimbus II PainPRO 00817170020086, Nimbus II Flex 00817170020093, Nimbus II Plus 00817170020161, Nimbus II EpiD 00817170020376, and Nimbus II EMS 00817170020109. These pumps were distributed nationwide from October 17, 2014, through February 21, 2024.

InfuTronix has issued a Medical Device Removal Letter to notify customers that a voluntary removal has been initiated for the pumps. The letter includes instructions on how to recognize device failure and the necessary actions to take when the failures occur.

Healthcare providers were given a specific set of instructions to ensure the proper performance of the accessory set associated with the pumps. They were advised to properly educate patients on replacing the batteries with new ones only, clearing the occlusion alarm properly, avoiding impeding the tubing set or placing pressure on the pump, and adhering to drug leakage and containment protocols.

These devices will not be available or supported after June 20, 2024, the manufacturer  noted, encouraging healthcare providers to seek alternative methods for their drug infusion needs based on the patient and medical expertise.

The manufacturer is advising customers who want to return there pumps to follow the instructions on the Medical Device Removal Letter, and contact customer service or their local distributor.

For more information, consumers can contact InfuTronix Customerservice@intuvie.com or call 508-650-2008, Option 8, Monday through Friday between the hours of 9:30AM and 5:00PM, Eastern Time (ET). For any adverse reactions or quality problems consumers can also use the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax.