The FDA recently announced an immediate product recall of Sigma Spectrum Infusion Pumps. The recall affects pumps with model numbers 35700BAX and 35700ABB that were manufactured between July 1, 2005 and January 15, 2014.
The Spectrum Infusion Pump is a medical product widely used by hospitals and home health care professionals. It is used to administer intravenous fluids into a patient’s vein, artery, or spine, or under the skin. Intravenous fluids can include blood, saline, or medicine.
The Sigma Spectrum Infusion Pump is equipped with a Master Drug Library of dose limits for most intravenous medications. The Master Drug Library automatically updates itself to ensure the device always has current dose limits for safe administration to patients.
Reason for the Spectrum Infusion Pump Recall
The manufacturer of the pumps, Baxter Healthcare Corporation, received more than 3,500 complaints of a particular system error for the above models. Specifically, the system error occurs when the computer believes the pump door is open when it is, in fact, closed. When this particular error occurs, the pump will stop any IV administration and sound an alarm to alert the medical professionals of the error. A medical professional will then have to reprogram the medication infusion into the pump and reset the alarm before medicine or other fluids may be administered again.
The requirement to reset and reprogram the pump will cause an interruption in drug therapy and may cause a significant delay before treatment resumes. This malfunction has caused adverse medical effects for nine different patients, and could possibly result in death.
What Should Spectrum Infusion Pump Customers Do?
Because of the potentially serious consequences of the malfunction, this recall is considered to be Class I, the most serious type of recall. Baxter Healthcare sent an urgent communication to all customers using Sigma Spectrum Infusion Pumps, notifying them of the possible malfunction and giving instructions to best handle the system error. Customers may report any malfunctions, issues, or adverse events to the FDA’s reporting department. Medical establishments using the pumps should contact Baxter Healthcare, and any patients using the pumps at home should contact their medical providers immediately.
If you suffer any serious injury or adverse effects because of pump malfunctions, you should contact an experienced product liability attorney to help you hold Baxter Healthcare responsible. Call Lopez McHugh LLP for assistance today.