Smiths Medical Issues Worldwide Notification Regarding Potential for Inappropriate Bolus or Loading Dose Delivery in Certain Medfusion® 3500 and 4000 Infusion Pumps

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

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.

Smiths Medical reports 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.

Affected Models:

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, MD20852
spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.