Device product
Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.
Z-0322-2018
Product summary
- Event
- Event 78588
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73,611
- Official record key
device-enforcement:Z-0322-2018
Official wording
Reason: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Code information: UDI 10885403810015. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa.
Derived failure modes
-
Unknown
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.