INFUSION PUMPS

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.

The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.

Paradigm ambulatory insulin infusion pumps.Manufactured by Medtronic.Models: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754.