INFUSION PUMPS

All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.

Medfusion¿ 4000 Syringe Infusion Pumps || Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.

All Plum A+ infusion pumps:Pump    List number  Plum A+ Infusion Pump    11971  Plum A+ 3 Infusion Pump System v 10.3    12348  Plum A+ Infusion Pump v 11.3    12391  Plum A+ 3 Infusion Pump v 11.3    12618  Plum A+ 3 with Hospira MedNet Software    20678  Plum A+ Driver    20792Manufactured by Hospira Inc.

General Hospital and Personal Use Devices

Volumetric infusion pumps

GemStar docking station for use with specific GemStar infusion pumps. The specific products potentially affected by the two problems are shown below: Affected product (docking station list numbers) Issue Potential to occur in conjunction with products 13075-XX-07 13075-XX-09 Pump fails to power up Gemstar phase 3 pump (13000-XX, 13100-XX, 13150-XX) Error code 11/003 on pump and infusion stops Gemstar phase 4 pump (13086-XX, 13087-XX, 13088-XX) External battery pack (13073-XX) If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification. There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert MDA/2013/078 .

Infusion pumps: Plum A+ single channel infuser systems.Manufactured by Hospira.Product codes: 11005, 11971, 12391, 20792.The following single channel infuser systems are affected by this alert:Plum A+ hyperbaric infusion system. Affected product code: 11005 Plum A+ single channel infusion system. Affected product codes: 11971 + 12391 Plum A+ infusion pump. Affected product code: 20792.