The U.S. Food and Drug Administration has announced that Smiths Medical, a medical device manufacturer, has sent an Urgent Medical Device Correction letter to inform its customers about potential risks associated with their Syringe Infusion Pumps.The letter notified users that the Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps suffer from 8 potential software issues. The devices are used by healthcare providers to deliver blood or blood products, drugs, antibiotics, lipids, enteral feedings and other therapeutic fluids through infusion tubing into a patient’s vein or through other routes of administration. The devices are typically used in neonatal and pediatric healthcare or for adults, in the ICU.
Smiths Medical is recalling their Medfusion 4000 and 3500 Syringe Infusion Pumps as a result of 8 software issues affecting various serial numbers and software versions. The software issues are as follows:
- False alarm for Primary Audible Alarm (PAA) system failure
- Network configuration may affect pump communications
- Abnormal circuit board behavior, which may cause internal clock system failure
- Unanticipated Depleted Battery Alarms
- Unanticipated clearance of Program Volume Delivered (PVD)
- Incorrect bolus or loading dose time display
- False alarm for Rate Below Recommended Minimum for Syringe Size
- Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues after system failure
The issues have the ability to cause serious harm or death to patients using the devices. Smiths Medical has notified the FDA that a total of 7 serious injuries and one death have occurred in association with these problems. Unanticipated depleted battery alarms accounted for 4 serious injuries. Another injury was caused when a pump continued to run after a system failure. Finally, 2 patients endured serious injuries and one death occured after a false alarm for a device failure.
In the Urgent Medical Device Correction letter, Smiths medical issued an overview of each issue, the affected pump models, a series of recommended actions for healthcare providers, the affected models, and the potential risk to patients. Additionally, the medical device manufacturer provided instructions to customers. The company advised customers to identify all affected devices and to ensure all users are aware of the notification, ensure that an additional pump is available for circumstances where an interruption to infusion can cause harm, to complete a response reform in order to demonstrate an understanding of the notification, and to contact Smiths Medical if any issues regarding the notifications arise.