Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names: lnfusomat Space Infusion System/Large Volume Pump, Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK
|
Model |
Unique Device Identifier |
Serial Number |
|---|---|---|
|
lnfusomat Space Infusion System/ Large Volume Pump |
04046963716752 |
52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337 |
| lnfusomat Space Large Volume Pump, Wireless |
04046964660887 |
430056,430119, 43015, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074 |
|
lnfusomat Space Large Volume Pump, Non-Wireless BATTERY PACK |
04046964708626 |
133238, 33975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, 810031 |
What to Do
- Do not use affected devices to deliver high-risk medications.
On August 6, 2024, B. Braun Medical Inc. sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
Interim actions for users
- Use devices that are not in the impacted serial number range to deliver high-risk medications.
- Place affected devices in care areas that do not administer high risk medications until the upstream occlusion sensor can be replaced.
If affected pumps must be used to deliver high risk medications before correction:
- Have a second pump available where possible.
- Additional monitoring may be required.
- Power the device down for 48 hours if it exhibits frequent false occlusion alarms. Place the device in an area that does not administer high risk medications and monitor closely.
- Contact B. Braun Medical Inc. at 1-800-627-7867 (1-800-627-PUMP) for technical support if the above measures cannot be implemented.
B. Braun Medical Inc. is working to schedule and update impacted devices, the following measures may aid in continued use of the pumps.
Actions for Customers
- Review the notice.
- Ensure that all users and other concerned personnel are informed about this voluntary correction.
- Ensure suitable interim measures are applied.
- Locate all devices with impacted serial numbers.
- Use stickers included in the letter to help clinical and biomedical engineering staff identify impacted devices.
- Record the total number of individual impacted units using the Product Correction Acknowledgement Form attached to the letter.
- Return the completed Product Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by fax at (610) 849-1197 or e-mail at PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two weeks, even if there are no affected devices in inventory.
- A Field Service Representative will contact customers to arrange a time and date to check affected pumps and replace sensors after the acknowledgement form is completed.
- Distributors should forward this notice to consignees.
Reason for Correction
B. Braun Medical Inc. is expanding an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to the already included models, Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, due to the risk that an alarm may sound to indicate a blockage (occlusion) when no occlusion exists. This will cause the pump to stop delivering medications, including critical high-risk medications like those that constrict blood vessels and raise blood pressure (vasopressors).
The use of affected product may cause serious adverse health consequences, including abnormal or unstable blood pressure (hemodynamic instability) and death.
There has been one reported injury and one report of death.
Device Use
Infusomat Space Infusion Pump systems are used by trained health care professionals in health care facilities. These pumps are used for adults and pediatric subpopulations ( neonates, infants, children and adolescents) for the intermittent or continuous delivery of fluids, medications, blood, and blood products.
Contact Information
Customers in the U.S. with questions about this recall should contact B. Braun Medical Inc. Postmarket Surveillance Department at 1-833-425-1464.
Additional FDA Resources
- Related FDA recall classification summary: B. Braun Medical Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm [11/17/2023]
- FDA’s Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.