FDA MedWatch~ Medfusion 4000 Syringe Pumps by Smiths Medical ASD: Class I Recall

https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-asd-inc-recalls-medfusionr-4000-syringe-pumps-due-malfunctioning-alarms-and-potential?utm_campaign=FDA%20MedWatch%20Medfusion%204000%20Syringe%20Pumps%20by%20Smiths%20Medical%20ASD&utm_medium=email&utm_source=Eloqua

A MedWatch Safety Alert was added to the FDA Medical Device Recalls webpage.  TOPIC: Medfusion 4000 Syringe Pumps by Smiths Medical ASD: Class I Recall - Due to Malfunctioning Alarms and Potential Interruption of Therapy AUDIENCE: Nursing, Health Professional, Risk Manager ISSUE: Smiths Medical has become aware of a software issue in the most recently updated Medfusion 4000 Syringe Pump Firmware, Version 1.7.0, that could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death. Recalled Product: Medfusion 4000 Syringe Pump with Firmware Version 1.7.0 Model numbers 4000-0107-01 and 4000-0106-01 Manufacturing Dates: June 25, 2019 Distribution Dates: September 27, 2019 to October 31, 2019 Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Read Class I Recall