Hospira Inc., GemStar Infusion System Class I Recall – Pressure Sensor Calibration Drift
Wednesday, December 18, 2013
ISSUE: The proximal and
distal pressure sensor calibration can drift resulting in the pump failing the
Proximal or Distal Occlusion Operational Test or resulting in an error being
reported during device setup or infusion (refer to Recall Notice for list of
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.
include a delay/interruption in therapy or over-infusion, which have a worst
case potential to result in significant injury or death.
BACKGROUND: 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.
Infusion Pumps (Models 13000, 13100, 13150, 13086, 13087, 13088) that were
either manufactured or had a pressure sensor replaced during servicing of the
pump since January 1, 2009 could be affected.
perform proximal and distal occlusion tests as defined in the GemStar Technical
Service Manual. If the device fails either of the tests, remove it from
clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM -
5:00 PM Central Standard Time) to report the issue and arrange for the return
of the device for recalibration. Add the performance of a proximal and distal
occlusion test to your yearly GemStar maintenance schedule.
professionals are advised to weigh the risk/benefit to patients associated with
the use of the device when administering critical therapies. Customers should
consider the use of an alternative pump, particularly in patients in which a
delay or interruption in therapy or an over-infusion could result in
significant injury or death.
professionals and patients are encouraged to report adverse events or side
effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
- Complete and
submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call
1-800-332-1088 to request a reporting form, then complete and return to
the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch
Safety Alert, including links to the Recall Notice HERE.
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 11/25/2013)