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
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