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
.