GemStar Infusion System, Class I Hospira Inc.

Company: Hospira Inc
Date of Enforcement Report: 11/25/2013
Class l:

PRODUCT

Hospira GemStar Infusion System
Models 13000, 13100, 13150, 13086, 13087, 13088
The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products. The device can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, the GemStar Pump is used for ambulatory patients.

REASON
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:

Cassette Check ? D
Cassette Check – P
Proximal Occlusion
Distal Occlusion
Pressure Calibration Error
Bad Pressure Sensor Event
Bad Pressure Sensor State
Distal Pressure is Out of Range
Proximal Sensor is Out of Range
A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down.

RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IllinoiI on 3/15/2013. Voluntary: Firm Initiated recall is ongoing.

FDA District
Chicago District Office

___________________________________

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.