The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Please be aware, this recall is a correction, not a product removal.
- Product Names: Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK
- Product Codes: See Recall Database entries above.
- Model Numbers: 8713051U and 8713052U
- Distribution Dates: October 26, 2022, to July 17, 2023
- Devices Recalled in the U.S.: 10,655
- Date Initiated by Firm: September 21, 2023
The Infusomat Space Volumetric Infusion Pump System, which includes the Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, and Non-Wireless BATTERY PACK, is intended to be used by trained healthcare professionals in healthcare facilities for use on adults, pediatrics, and newborns for the intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products.
Reason for Recall
B. Braun Medical, Inc. is recalling the Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms. On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications, such as high-risk medications like vasopressors. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
There have been 51 complaints, one reported injury, and one death related to this recall.
Who May be Affected
- People that require intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products especially those that require high-risk medication.
- Health care providers that deliver intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products to their patients.
What to Do
On September 21, 2023, B. Braun Medical, Inc. sent all affected customers an Important Medical Device Advisory.
The letter requested customers to:
- Move the device to areas where only low-risk medication is delivered and to not use the device for high-risk medications.
- Ensure a second pump is available if high-risk medication is being infused, thereby allowing the continued use of the impacted device.
The firm will also reach out to customers and send out technicians to replace the occlusion pressure sensors with a second source of qualified sensors.
The firm plans on having scheduled services to update the impacted devices. Customers were provided with stickers to mark the affected units and were informed of measures to aid in continued use of the pump such as only using non-impacted devices for the delivery of high-risk medications and placing impacted units in care areas that do not administer high-risk medications. The firm agreed during the letter editing process in September 2023 that the stickers would not be the sole determinant of which pumps are remediated by the firm.
If you have questions about this recall, contact B. Braun Medical Inc. at 1-800-627-PUMP (1-800-627-7867).
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.