FDA Announces B. Braun Medical Inc.’s Correction for lnfusomat Space Infusion System and Pumps
On September 17, 2024, the U.S. Food and Drug Administration (FDA) announced that (https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-correction-b-braun-medical-inc-issues-correction-lnfusomat-space-infusion-systemlarge?utm_medium=email&utm_source=govdelivery) B. Braun Medical Inc. was issuing an urgent device correction for its Infusomat Space Infusion system and pumps. The FDA said that the recall involves correcting the devices, not removing them from where they are used or sold. The agency identified it as a the most serious type of recall, where use of the device without correction may cause serious injury or death.
The FDA said that B. Braun Medical Inc. is expanding an earlier recall (https://www.fda.gov/medical-devices/medical-device-recalls/b-braun-medical-inc-recalls-infusomat-space-large-volume-pump-wireless-and-infusomat-space-large) to add lnfusomat Space Infusion System/Large Volume Pump, Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK because of the risk that an alarm may sound to indicate an occlusion when none exists. This will cause the pump to stop delivering medications, including critical, high-risk medications like vasopressors.
The use of affected product may cause serious adverse health consequences, including hemodynamic instability and death. To date, one injury and one death have been reported.
On August 6, 2024, B. Braun Medical Inc. sent all affected customers an urgent medical device correction letter regarding the following affected devices.
| Model | Unique Device Identifier | Serial Number |
| lnfusomat Space Infusion System and 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 |
In the letter, B. Braun Medical Inc. recommended that customers take the following actions:
- Use devices that are not in the affected serial number range to deliver high-risk medications.
- Place the affected devices in care areas that do not administer high-risk medications until the upstream occlusion sensor can be replaced.
- If you must use the affected pumps to deliver high-risk medications before the correction:
- Have a second pump available where possible.
- Monitor the device closely.
- If a device exhibits frequent false occlusion alarms, power it down for 48 hours, place it in an area that does not administer high-risk medications, and monitor it closely.
- Contact B. Braun Medical Inc. at 800-627-7867 for technical support if you cannot implement these measures.
B. Braun Medical Inc. said that is working to schedule and update the affected devices. In the meantime, it advised customers to:
- 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 the affected serial numbers.
- Use stickers included in the letter to help clinical and biomedical engineering staff identify affected devices.
- Record the total number of individual affected units using the product correction acknowledgement form attached to the letter.
- Return the completed form to B. Braun Medical Inc.’s quality assurance department by fax at 610-849-1197 or e-mail at PA_QualityAssurance.BBMUS_Service@bbraunusa.com (mailto:PA_QualityAssurance.BBMUS_Service@bbraunusa.com) within two weeks, even if there are no affected devices in inventory.
- Distributors should forward the notice to consignees.
U.S. customers with questions about the recall should contact B. Braun Medical Inc. postmarket surveillance department at 833-425-1464. Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).