Alaris Pump module Model 8100

Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

General Hospital and Personal Use Devices

2

No

US and Canada

Alaris Pump Module model 8100

Medical Device Safety Alert: BD Alaris Pump module model 8100

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; || Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; || Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. || The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

Model 8100; Lot/Serial numbers-various

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Alaris Pump Module Model 8100 (formerly Medley Pump Module) || Subsequent Product Code: FPA. || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.

Alaris Pump Module model 8100. || Subsequent product code: FPA || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.