Gemstar Infusion Problems Can Cause Severe Injury, Death: FDA
Federal health regulators indicate that recalled infusion pump docking stations may pose a risk of serious injury or death, after several reports have suggest that problems with the device may cause a delay in treatment and put patients at risk.
The FDA determined last week that it a GemStar Docking Station recall should be categorized as a class I medical device recall, meaning continued use of the device carries a risk of serious injury or death.
The recall was originally announced by Hospira on February 18, following at least two customer complaints indicating that the docking stations may fail to power up the GemStar infusion pumps or display an error code when used with an external battery pack accessory, potentially causing delays in treatment. While no serious injuries have been reported to date in association with the docking stations, the FDA warns this could cause life-threatening health problems for patients relying on the infusion pumps.
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The GemStar Docking Stations are used in a post-operative hospital setting to supply a convenient source of power for the GemStar infusion pumps used to administer anesthesia into the spine prior to child birth or for other general infusions, such as medicines, feeding solutions, antibiotics, and cardiovascular solutions.
The docking stations may create dangerous circumstances during use because when used with a GemStar Phase 3 infusion pump, the pump may fail to receive power from the docking station, which could cause a delay in treatment.
When the docking stations are used in conjunction with the Gemstar Phase 3 pump or the GemStar Phase 4 pump and an accessory external battery pack the docking station may display an error code of “11/003” and begin to sound an audible alarm indicating the pump is receiving excessive input voltage (more than 3.6 volts). When the pumps receive more than required voltage the machines will discontinue administering the infusion, causing a delay in therapy.
The recall affects GemStar docking stations with product code 13075 when used with GemStar Phase 3 and 4 Pumps with listing numbers 13000, 13100, 13150, 13086, 13087, 130088. The docking stations are the only items officially recalled at this time.
The affected docking stations were manufactured by Hospira Inc., of Lake Forest, Illinois from July 2002 through March 2013 where they were then distributed for sale from July 2002 through December 2013.
On February 18, Hospira sent an Urgent Medical Device Correction notice to all customers instructing them that there is no reason to return the product, but directed users to follow the instructions laid out in the letter. Those instructions include turning the GemStar Phase 3 pumps on first before connecting to the docking station to prevent failure to power up. Secondly, the instructions state users should not use an external battery pack in conjunction with the docking stations. The company claims this will prevent the 11/003 error code.
Another GemStar Infusion System Class I recall was announced by the FDA on April 26, due to a risk that the lithium battery voltage level may malfunction if the voltage level drops below 2.4 volts.
Hospira instructed customers to make all potential users aware of the dangers and solutions and asses the benefit/risks of using the docking stations and if need be switch to an appropriate alternative options. Customers may contact Hospira if they experience any malfunctions at 1-800-441-4100 or by email at ProductcomplaintsPP@hospira.com.
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