 |
| Hospira is recalling the docking station used to power its GemStar infusion pump.--Courtesy of Hospira |
Hospira ($HSP) is initiating a nationwide recall of the docking station used to power up the GemStar infusion pump.
The GemStar Docking Station may fail to power up the GemStar Phase 3 pump as intended, Hospira said in a statement. In addition, when the docking station is used in conjunction with an external battery pack, it may stop infusion in the GemStar Phase 3 or GemStar Phase 4 pump.
Infusion will be stopped "if the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input," the statement says. The scenario results in an audible alarm and the display of alarm code 11/003.
Either problem could result in serious injury or death, Hospira says, adding that so far there have been no reported adverse events as a result of the malfunctions. The company issued an Urgent Medical Device Correction notice to customers about these issues in February, according the statement.
Hospira recommends two corrections and says there is no need to return the docking station. To prevent the failure to power up, turn the infusion pump on before connecting it with the docking station. To reduce the potential for an 11/003 error code, remove the external battery pack from the docking station and pump before installing the pump in the docking station, the statement says. It also advises against using the docking station in conjunction with the external battery pack.
The Illinois company has been beset by regulatory problems with its pumps, and the resultant costs have marred Hospira's financials. Last year the GemStar ambulatory pump was the subject of a Class I recall. Shortly thereafter Hospira decided it would discontinue the GemStar family of infusion devices.
The recall statement reiterates the decision and says the company will no longer support the devices as of July 31, 2015.
Adding to the company's safety woes, FDA on Friday put the October 2013 recall of the Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps into its most serious Class I category, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
- read the release
Related Articles:
Hospira pulling the plug on troubled devices
Hospira endures another Class I pump recall
After FDA ban, Hospira creeps back into the infusion game with Q Core deal