BIO Medical, Healthcare Institutions, Life Sciences, Medical Devices, Regulatory Focus News Letter

USFDA Class I Recall,the most serious type of recall

Good Morning, Welcome to FWQRC Regulatory Focus News Letter…

Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries 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
  • Devices Recalled in the U.S.:  627
  • Date Initiated by Firm: October 28, 2019
  • Device Use

The Smiths Medical ASD Medfusion 4000 Syringe Pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner.  Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for the adult population.

Reason for Recall

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.

Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.

  • Who May be Affected
  • Healthcare providers using the Smiths Medical ASD, Inc.  Medfusion® 4000 Syringe Pump
  • Patients who receive therapy delivered by the Smiths Medical ASD, Inc. Medfusion® 4000 Syringe Pump

What to Do

On October 28, 2019, Smiths Medical sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products.

The Recall Notice from Smiths Medical advised customers to:

  • Locate all Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 in their possession. The firmware version of the pump can be identified by powering on the unit and observing the firmware version displayed on the screen.
  • Determine the number of affected devices in their possession and complete the provided Recall Notice Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com even if they do not have any affected product in their possession. All affected product must be returned to Smiths Medical for processing.
  • Upon returning the Response Form, Smiths Medical will provide a shipping label to return the affected product. Include a copy of the completed Response Form inside each box of returned product to facilitate processing. Ensure boxes are sealed and labeled with the facility name prior to shipping.
  • If they distributed any of the potentially affected products identified in this Recall Notice, they should immediately notify the recipients of the potentially affected products by forwarding them a copy of this Recall Notice.

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