lnfusomat Infusion Pump Recall Expanded To Include Additional Devices That May Experience Life-Threatening Malfunction

An earlier recall of Infusomat infusion pumps has been expanded to include more models and serial numbers, after the manufacturer determined that sensors on more devices may malfunction and cause the pumps to fail to deliver critical medications, potentially leading to severe or life-threatening injuries.

Braun Medical first issued the Infusomat infusion pump recall in September 2023, following 51 complaints of problems with the device, including at least one injury and one death. The manufacturer determined that the problems occurred when the products’ upstream occlusion sensors registered false blockages, stopping the pumps from delivering life-saving medications like vasopressors, which constrict blood vessels to increase blood pressure.

Due to concerns that additional models may experience the same malfunction, the U.S. Food and Drug Administration (FDA) posted information this week about an expanded Infusomat recall, warning medical providers not to use the devices to deliver high-risk medications.

The Infusomat’s malfunctioning upstream occlusion sensor is designed to sound an alarm when a blockage occurs in a patient. In the case of the impacted products, this alarm will sound when no blockage is present, stopping the steady flow of life-saving medications, potentially leading to abnormal or unstable blood pressure, which could injure or kill the patient.

The current recall does not require that the impacted devices be removed from where they are used or sold. Instead, it is an acknowledgement that the infusion pumps need correction by the manufacturer. However, the FDA has still categorized the action as a Class I medical device recall, suggesting that continued use of the products poses a risk of severe injury or death.

Recalled Infusomat Infusion Pumps

Braun Medical’s initial Infusomat recall from September 2023 included the Infusomat Space Large Volume Pump Wireles and the lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK. However, the manufacturer expanded this recall on August 6, 2024, by sending an urgent medical device correction letter to all potentially affected customers.

Products affected by the expanded recall now include the lnfusomat Space Infusion System/Large Volume Pump, Infusomat Space Large Volume Pump Wireless and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, with the following serial numbers:

• lnfusomat Space Infusion System/Large Volume Pump with unique identifier number 04046963716752 and serial numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279 and 339337
• Infusomat Space Large Volume Pump Wireless with unique identifier number 04046964660887 and serial numbers 430056,430119, 43015, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843 and 814074
• lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK with unique identifier number 04046964708626 and serial numbers 133238, 33975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680 and 810031

Customers who believe they may still have one of the recalled Infusomat infusion pumps in their inventory have been told to immediately stop using the device for the delivery of high-risk medications until the upstream occlusion sensor can be replaced. The impacted products do not need to be returned to the manufacturer. Infusomat devices that do not have an affected serial number are safe to continue using.

Braun Medical recommends that all customers who have received a correction letter ensure necessary personnel are informed of the problem, locate the devices with impacted serial numbers, and use stickers to help staff know which devices to no longer use.

If a device must continue to be used until the sensor can be replaced, customers should monitor the device closely and have a second pump available if possible, or power the device down for 48 hours and place it in an area that does not use high-risk medications.

If those measures cannot be taken, the customer should contact Braun Medical for technical support at 1-800-627-7867.

Even if there are no affected devices in a customer’s inventory, those who received correction letters should still record the total number of impacted units in their possession, using the product correction acknowledgement form attached to the letter, and return that form within two weeks by fax to Braun Medical’s Quality Assurance Department at (610) 849-1197 or email it to the company at PA_QualityAssurance.BBMUS_Service@bbraunusa.com.

U.S. customers with questions about the Infusomat recall should contact Braun Medical’s Postmarket Surveillance Department at 1-833-425-1464.

Professionals and consumers who are aware of any issues with an Infusomat infusion pump can report their experiences using the affected devices to MedWatch, the FDA safety information and adverse event reporting program.