Weitz & Luxenberg is taking cases of patient deaths, coma, or serious injury resulting from recalled BD Alaris Systems. Becton, Dickinson and Company (BD), has issued a series of recalls for different models and modules of its Alaris System, consisting of infusion and IV systems and software, with four recalls announced this year alone.
The U.S. Food and Drug Administration (FDA) has classified three of the BD Alaris recalls from this year as Class I. This means the FDA considers the recalled devices to potentially present “a situation in which there is a reasonable probability that the use of or exposure to…will cause serious adverse health consequences or death.”
“When devices that are designed to make sure patients get the care they need don’t function correctly, people can suffer irreparable harm,” said Ellen Relkin, Weitz & Luxenberg’s practice group chair for defective drugs and medical devices. “We can help you try and get justice for the faulty devices that affected your health care and quality of life by holding the manufacturers of these devices responsible.”
Infusion Problems, Patient Monitoring Problems with BD Alaris Devices
The BD Alaris line of products was first approved by the FDA in 1995, with many different models subsequently approved. Many of the models in the BD Alaris line of products have been recalled this year, classified as Class I recalls by the FDA, including the:
- Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits,
- Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits,
- BD Alaris Syringe Module Model 8110.
- BD Alaris PCA Module Model 8120.
In addition, the most recently recalled device, has been classified as a Class II recall:
- BD Alaris EtCO2 Model 8300.
Injuries and Deaths Reported
The first Alaris recall initiated by BD this year was for several models of the Alaris System Infusion Pumps, totaling 774,000 devices. BD reported numerous problems with the recalled devices, including software and system errors, delays or errors in programming, low battery alarm failures and other alarm errors. Any of these errors could cause “delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).”
BD reported 55 injuries and one death connected to the recalled device’s problems.
On August 4, 2020, BD initiated another recall for an Alaris device, the Alaris PC Unit Model 8015, totaling over 305,000 affected products. These devices were recalled due to the potential for keys in their keypads to “become unresponsive or stuck” which could “lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device.”
BD reported receiving 1,186 complaints about these recalled devices, including one reported injury. The same day, BD also issued a recall for the BD Alaris Syringe Module and the BD Alaris PCA Module, and Syringe/PCA Sizer Sensor Replacement Kit, of various models, totaling over 141,000 devices. The devices were recalled due to the potential for them to, again, “result in delays in infusion, under-infusion, or over-infusion.”
Several of these recalled devices, such as the Alaris PCA and the Alaris Syringe, have been the subject of previous large Class I or Class II recalls, some detailing similar problems as the new recalls.
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has several reports of patient adverse events occurring due to BD Alaris infusion sets or systems, several detailing patient over-dosing or under-dosing due to the Alaris devices used.
W&L Can Help Patients Injured by a Recalled BD Alaris System
Weitz & Luxenberg encourages anyone who experienced serious injury after a recalled BD Alaris System was used during their care to contact the firm using the online form or by calling (800) 476-6070 for a free consultation. Weitz & Luxenberg also encourages families of patients who died as a result of a recalled BD Alaris System to contact the firm.
BD is headquartered in Franklin Lakes, Bergen County, New Jersey. Relkin has been appointed by judges in Bergen County to serve as the head of steering committees representing plaintiffs in other medical device and pharmaceutical product liability actions there. Cases on behalf of victims injured anywhere in the country may be filed against BD in Bergen County, based on court rules.
Weitz & Luxenberg’s attorneys have experience with lawsuits against the manufacturers of defective medical devices. We have won more than $12 billion in verdicts and settlements for our clients. Reach out to us, so we can try and help you.