GemStar Infusion Pump Recall Issued Due to Power Supply Problems
About 13,000 GemStar Infusion Power Supply devices have been recalled, after the manufacturer received at least 20 reports of problems where the devices were not properly powered, potentially causing lower levels of treatment to be administered to patients.
On November 5, the FDA indicated that a recent Hospira Gemstar infusion pump recall has been categorized as a class I medical device recall, suggesting that the agency believes power supply problems with the devices could lead to serious injury or death.
The recall came after consumer complaints indicated that the devices failed to properly administer their planned infusion therapy due to low power supply, including one report of the device overheating and smoking. While this poses a serious risk for patients, no injuries or deaths have been linked to the recall to date.
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The recalled GemStar Power Supply, 3VDC Wall Mount and Desk Top devices are an accessory that provides power to the GemStar Infusion Pump, which is used in hospitals and at the in-home patient level to deliver controlled amounts of fluid including medicines, blood, blood products, nutritional foods, and other mixtures into a patient’s body in controlled amounts.
The FDA has established the products are dangerous because if the power supply fails to operate the Infusion Pump, planned infusion therapy may be delayed or not properly administer the correct dosages which could lead to too much or too little fluid, too high or too low blood pressure, slow or fast heart rhythm, shock, trauma, burns, stroke and even death. The FDA is also warning the devices may be prone to catch on fire if an electric shock or spark from the malfunctioning pump is in an oxygen-rich environment.
The recall includes the GemStar Wall Mount power supply devices with list number 13026-04-05 with manufactured dates ranging from January 2013 through March 2013 and distribution dates ranging from February 2013 to April 2013. The Desk Top Power Supply is labeled with list number 13072-04-05 and was manufactured from October 2011 through March 2013 and distributed from November 2011 through April 2013.
The GemStar power supply devices were manufactured in China by and Bridge Power Corporation and distributed to Hospira, Inc. of Lake Forest, Illinois where they were distributed worldwide to hospitals and medical care equipment providers. The FDA anticipates an estimated 13,002 units affected by this recalled were distributed across the globe with 5,687 of those units sold in the U.S. alone.
The FDA has categorized the recall as a Class I recall indicating it is the most dangerous type. Class I status recalls means that there is a reasonable probability that the use of the product will cause serious adverse health consequences including death.
Hospira sent an “Urgent Medical Device Correction” letter on February 3, 2014 to all direct customers, outlining the problem and instructions to avoid arcing, wiggling, or dropping the power supply on hard surfaces to lessen the chance of any internal device failure. The letter also detailed for customers or providers with remaining inventory to inform potential users of the dangers, complete and return the reply form in the device correction letter, remove the power supply from the Infusion Pumps, and to call Stericylce at 1-888-641-9735 to receive a reply form to fill and return.
Customers with further questions are encouraged to contact Hospira Global Complaints at 1-800-441-4100 to report any concerns or malfunctions.
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