Worldwide Notification Regarding Potential for Inappropriate Bolus or Loading Dose Delivery in Certain Medfusion® 3500 and 4000 Infusion Pumps
Wednesday August 19 2020
Vanessa Krier at email@example.com
Smiths Medical has become aware of an issue where certain Medfusion® 3500 and 4000 syringe pumps with firmware versions listed below may not operate as expected. Due to a software error, if a bolus or loading dose is interrupted and a specific sequence of events occurs, over- or under-delivery of a bolus or loading dose may occur.
Medfusion® 3500 Syringe Pump – Firmware Version 6.0.0
Medfusion® 4000 Syringe Pump – Firmware Versions 1.5.0; 1.5.1; 1.6.0; 1.6.1; 1.7.0
Affected Models listed above were distributed by Smiths Medical from 2013 to 2020. The firmware version of these pumps may be identified by powering them on and observing the firmware version displayed on the screen. This communication, and the associated Recall Notice issued by Smiths Medical to consignees of Affected Models, is applicable only to the Affected Models listed above.
In the Affected Models listed above, when an operator: (1) Programs a Bolus or Loading Dose, (2) Initiates the Bolus or Loading Dose, (3) Interrupts the Bolus or Loading Dose, (4) Primes the pump, and (5) Resumes the Bolus or Loading Dose instead of beginning a new infusion, over-delivery or under-delivery of medication may occur.
WARNING: Continuing an interrupted bolus or loading dose may result in medication over-delivery or under-delivery which can result in serious injury or death.
INSTRUCTIONS TO CLINICIANS
For any reason, when a bolus or loading dose delivery is interrupted and mechanically primed using the PRIME FUNCTION, cancel the bolus or loading dose and begin a new infusion to avoid potential over-delivery or under-delivery of medication.
This action has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA). Smiths Medical has received a total of 4 reports associated with this issue, all involving over-delivery of medication. One of these reports resulted in a serious injury; there were no reports of deaths.
Smiths Medical is issuing Recall Notices and Response Forms to consignees in possession of Affected Models and will notify consignees of Affected Models when software updates are available to correct this issue. Software updates will be provided at no cost to all consignees and are expected to be available in late 2021.
FDA MedWatch Reporting
Adverse reactions or quality problems experience with the use of these products may also be reported to the FDA’s MedWatch Program by:
- MedWatch website at www.fda.gov/medwatch
- Phone: 1-800-FDA-1033
- Fax: 1-800-FDA-0178
- Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852