B. Braun Medical, Inc. has issued a Class I recall, the most serious type, for its Infusomat Space Large Volume Pump, Wireless, and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK. The recall, identified by the FDA, is categorized as a correction rather than a product removal. The affected devices, used in healthcare facilities for delivering fluids and medications, pose a serious risk of injury or death due to faulty occlusion alarms.
Recalled Product Details:
- Product Names: Infusomat Space Large Volume Pump, Wireless, and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK
- Product Codes: Refer to Recall Database entries
- Model Numbers: 8713051U and 8713052U
- Distribution Dates: October 26, 2022, to July 17, 2023
- Devices Recalled in the U.S.: 10,655
- Initiation Date: September 21, 2023
Device Use:
The Infusomat Space Volumetric Infusion Pump System, subject to the recall, is designed for use by trained healthcare professionals on adults, pediatrics, and newborns to deliver parenteral fluids, medications, blood, and blood products intermittently or continuously.
Reason for Recall:
The recall is prompted by faulty occlusion alarms on certain models, causing false alarms and potential interruptions in medication delivery, especially critical medications like vasopressors. There have been 51 complaints, one injury, and one reported death associated with this issue.
Who May be Affected:
- Individuals requiring intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products, particularly those in need of high-risk medications.
- Healthcare providers delivering such fluids and medications to their patients.
Actions to Take:
Affected customers received an Important Medical Device Advisory on September 21, 2023, with the following instructions:
- Move the device to areas where only low-risk medication is administered.
- Do not use the device for high-risk medications.
- Ensure a second pump is available for the infusion of high-risk medications.
- B. Braun Medical, Inc. will replace occlusion pressure sensors with qualified sensors and schedule services to update impacted devices.
Contact Information:
For inquiries about the recall, contact B. Braun Medical Inc. at 1-800-627-PUMP (1-800-627-7867).
This information is crucial for the safety of both patients and healthcare providers, emphasizing the importance of immediate action in response to the recall.