Nearly 2,500 Alaris Infusion Pumps are being recalled, following dozens of reports of problems where components cracked or separated, which is believed to have resulted in at least one death.
The FDA announced an Alaris Infusion Pump Module Model 8100 recall on April 30; specifically impacting those purchased and/or installed by Pacific Medical Group, which was doing business as Avante Health Solutions. The recall came after 62 reports of the front bezel component cracking or separating, which can lead to an inaccurate delivery of fluids to patients.
The Alaris Pump Module System is an infusion pump used to deliver medications, blood, and blood products into a patient’s body in a controlled manner. The system is commonly used in hospitals and other healthcare facilities.
The front bezel component is key in the infusion pump working properly, and those affected by the recall used aftermarket front bezel components manufactured by Pacific Medical Group, which is announcing the recall. Pacific Medical Group warns that if the bezel posts are separated or cracked it could cause a free flow of fluids into the patients, resulting in too much or too little of the fluids being delivered. This could also cause an interruption of fluids into the patient.
In addition to the 62 reports of incidents, there is one death which may have been related to the problem as well, according to the company.
The recall affects the Alaris Model 8100 Infusion Pumps purchased and/or installed by Pacific Medical Group, doing business as Avante Health Solutions. They were distributed between July 10, 2020 and February 18, 2021. A full list of affected serial numbers can be found here.
An estimated 2,452 units are affected by the recall. All of the affected units would have been serviced or repaired by Pacific Medical Group.
Pacific Medical Group sent a Medical Device Recall Notification to affected customers on March 24, first notifying them of the situation. However, on April 30 the FDA gave the recall a Class I designation, indicating the agency believes the problem can cause serious injuries or death to patients.
Customers have been asked to identify if they have the affected product, remove the affected devices from clinical use and immediately quarantine them until the affected parts can be returned to the manufacturer and to contact Pacific Medical Group customer service at 800-449-5328 to begin the replacement process or if they have any questions. They can also send an email to firstname.lastname@example.org.
Alaris Infusion Pumps have been the subject of numerous recalls in recent years. This is the third recall announced for April alone.
On April 16, 150,000 BD Alaris Infusion pumps were recalled due to problems with the keypad, and on April 19, just under 500 units were recalled due to related front bezel component problems.
In September 2020, the FDA announced four Alaris pump recalls for a variety of problems, including malfunctioning key pads, incorrect module types and sizes, and channel errors, all of which could delay or prevent fluid or medication delivery and put patient lives at risk.
That series of recalls comes just months after a BD Alaris infusion pump recall issued in March 2020 affecting 774,000 infusion pumps distributed to hospitals and medical facilities nationwide, due to software errors that have been linked to dozens of injuries, and at least one death.
In 2019, Becton Dickinson was forced to remove more than 150 million Alaris infusion sets from the market due to issues where the tube may collapse during use, leading to the risk of medication overdose to patients.