The U.S. Food and Drug Administration (FDA) has announced the recall of an infusion pump manufactured by CareFusion called the Alaris Pump Module, Model 8100.
What Is the CareFusion Alaris Pump 8100?
An infusion pump is a medical device that regularly injects controlled quantities of medications into patients intravenously, intra-arterially, or as an epidural. They can be used on patients of any age.
The Alaris Pump 8100 Might Cause Serious Injury and Death
On July 20, 2012, CareFusion sent a letter to customers informing them that the Alaris Pump 8100’s keypad overlay could loosen, peel away, or separate from the keypad door assembly. If this occurs, it’s possible that liquid medication could find its way into the keypad and cause a malfunction, which stops the infusion pump and triggers an alarm. For some patients, not receiving regular injections of medication can result in severe injury or death.
Also on July 20, 2012, CareFusion sent another letter to customers notifying them that it had received reports that the Alaris Pump 8100 could suffer motor stalls when operating at high infusion speeds. Most such motor stalls occurred at 900 mL/hr, but both CareFusion and the FDA are concerned that they could occur at lower speeds.
If an infusion pump suffers a motor stall, the device stops delivering medication to patients. Some patients with serious medical conditions might not receive life-saving treatment possibly resulting in serious injuries or death. According to the FDA, when a motor stall occurs, the Alaris Pump 8100 will display the error code “242.4030” and sound an alarm.
The FDA classifies both recalls as Class I, the most serious kind, because there is “a reasonable probability that use of the product will cause serious adverse health consequences or death.” The FDA also provides a link to CareFusion’s list of serial numbers for consumers to see if theirs is affected by motor stalls.
In November 2012, CareFusion announced that postmarket studies showed that the Alaris Pump 8100 could also cause pulmonary embolism because tiny air bubbles might pass undetected into patients’ bodies. Air bubbles in the circulatory system can be deadly because they can cause blockages in blood vessels. Patients with an atrial septal defect are at greater risk.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a CareFusion Alaris Pump 8100 lawsuit on your behalf if necessary.
If you used an Alaris Pump 8100 and believe it harmed you, contact RLG today.