| Developers: | BD (Becton Dickinson) |
| Date of the premiere of the system: | September 2020 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2023
Payment of $85 million for concealment of marriage in infusion pumps
On December 21, 2023, the U.S. Securities and Exchange Commission (SEC) reported that Becton Dickinson had filed settlement documents for a class action lawsuit related to defective infusion pumps. The manufacturer will pay $85 million to complete the proceedings and withdraw all claims.
We are talking about devices of the Becton Dickinson Alaris family. They are intended for administration of various therapeutic solutions, including analgesics, antimicrobials, blood preparations, chemotherapy preparations, nutrients, etc. Concomitant software allows the medical facility to collect data on optimal intravenous injection practices, offering dosing recommendations to ensure a personalized, profile-based approach to patients. Each profile contains a specific drug library and corresponding pump configurations suitable for a particular application.
It turned out that the Alaris hardware software contains vulnerabilities that allow attackers to steal patient data. In addition, compatibility issues with Cardinal Health Monoject syringes have been identified. Becton Dickinson initiated a recall of defective products, and also released a software update. However, a class action lawsuit was filed against the manufacturer: Becton Dickinson is alleged to have secretly made changes to Alaris products for five years without approval from the U.S. Food and Drug Administration (FDA).
As part of the settlement of the proceedings, the documents were transferred to the US District Court for the District of New Jersey. The company says it has decided to pay compensation in order to avoid the costs, uncertainties and risks associated with the continuation of the lawsuit.[1]
Recall of 1 million defective infusion pumps that inject too much or little medication
On December 1, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of Becton Dickinson infusion pumps due to compatibility issues with Cardinal Health Monoject syringes. When using this equipment, the introduction of an incorrect volume of drugs may be observed, which poses a threat to the health and life of patients.
We are talking about Becton Dickinson Alaris Syringe Module, Alaris PCU and Alaris PCA Module. They are designed to deliver medicines or other fluids to the body. The devices are used, among other things, for patient-controlled analgesia (PCA), when a person independently controls the administration of an analgesic.
The FDA notice says Alaris infusion pumps are certified for use with Monoject syringes. However, the dimensions of these syringes were changed during the rebranding process from Covidien Monoject to Cardinal Health Monoject. This causes the infusion equipment to incorrectly estimate the volume of fluid in the syringe. Thus, there is a risk of overdose or, conversely, insufficient administration of the drug. In some cases, other problems are observed: pumps refuse to work, there is a delay in the formation of alarm signals about occlusion, etc.
As of early December 2023, there have been reports of 13 incidents involving Becton Dickinson Alaris equipment when shared with Monoject syringes. Deaths by the specified date were not recorded. The recall includes more than 1 million devices manufactured by Becton Dickinson with model numbers 8110, 8015 and 8120. The equipment was delivered to the market from June 19, 2004 to September 22, 2023.[2]
Software Vulnerability Notification in Infusion Systems
On February 16, 2023, Becton Dickinson issued a voluntary notice of software vulnerability in Alaris Infusion Central infusion systems. Due to this malfunction, attackers can steal patient data.
According to the materials provided by the manufacturer, in the infusion systems of Alaris Infusion Central software from the company, versions 1.1 to 1.3.2, may contain a password that can be restored after installation. The database does not store patient health information, although some installations on sites may store personal information.
Alaris pumps are separately supplied with software or a tablet called Alaris Infusion Central, the software allows medical professionals to track infusion data on a PC and manage patient infusions transmitted by Alaris Plus and Alaris neXus pumps. Alaris Infusion Central is not sold in the United States. Despite the similar product family names, Becton Dickinson reports that the vulnerability does not affect users of Alaris PCU 8015 or Alaris Systems Manager.
Becton Dickinson engineers said they have revised the software installation procedure to prevent vulnerability in subsequent installations. They recommend that users periodically change passwords and provide physical access control. Only authorized administrators must have access to the Alaris Infusion Central server. Becton Dickinson reported that the vulnerability was rated 7.3, which means a high rating in the overall vulnerability assessment system.
According to Drug Delivery Business News, BD's report on the presence of problems in Alaris has become another problem for the manufacturer in this market. Earlier, the company was forced to recall its infusion pumps due to numerous errors in their operation. BD also worsened its revenue forecasts after the suspension of new Alaris deliveries, the publication said.[3]
2021: Recall of defective infusion pumps that have jammed keys
In early March 2021, Becton Dickinson began recalling defective Alaris infusion pumps, which have jammed keys. The recall was assigned to class I, that is, malfunctions of the device can cause serious injuries or pose threats to the patient's life.
The latest BD recall, initiated on March 3, 2021, concerns the modular BD Alaris system, which includes an infusion pump, a vital signs control system with Guardrails Suite MX control unit and up to four removable infusion modules or monitoring modules (channels).
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Regulators are recalling the Alaris pump module because unexpected system failures occur due to liquid entering the keyboard, and the keys stop responding to presses or jam. This can cause the infusion to be delayed or interrupted, and may also prevent doctors from changing infused fluids or medications on damaged devices in time. Such delays or interruptions in therapy can lead to the development of serious injuries or even death of the patient.
At the beginning of April 2021, regulators received 79 complaints about defective devices, but there were no reports of injury or death. The latest recall of defective devices is not related to the recall of the Alaris 8100 module keyboard due to key jamming, which was held in August 2020.
Potentially defective infusion pumps were manufactured between January 15, 2019 and December 5, 2019 and distributed on the market between January 23, 2019 and December 5, 2019. At the beginning of April 2021, 145,492 devices were recalled in the United States.
BD has suspended deliveries of Alaris pumps from 2020 after the FDA required a comprehensive product registration application with multiple software fixes. Alaris infusion pumps were used only by paramedics providing emergency medical care.[4]
2020
BD allocated $244 million to cover costs associated with the call of defective infusion pumps
In mid-November 2020, Becton Dickinson allocated $244 million to cover future costs associated with the recall of defective Alaris infusion pumps. The company has suspended pump deliveries since early 2020, when regulators demanded a complete fix to the pumps' software. Now these pumps are supplied only to those institutions where emergency medical care is possible.
Alaris's problems have seriously affected the entire Becton Dickinson company, which continues to deal with the consequences of the COVID-19 pandemic. The company plans to submit a full software fix report to regulators at the end of the second or beginning of the third quarter of the fiscal year (tentatively in the spring of 2021), CEO Thomas Polen said during the announcement of its 2020 financial results.
 | The highest priority of the organization is still to prepare a full report on Alaris, obtain permission to sell it and return infusion pumps to the market for further development, says Polen. - Over the last quarter, the team working on fixes managed to achieve outstanding results and reduced the risks associated with the device. |  |
In the meantime, the company continues to warn its customers about potential problems with infusion pumps. In November, the company warned of cybersecurity issues; the warning applied to the BD Alaris Infusion Pump, model 8015, version 9.33.1 and earlier, and to the Alaris System Manager, version 4.33 and earlier. Another Becton Dickinson notice issued on November 13 in Germany involved the Alaris GW and GW800 volumetric pumps. The company has updated the guidelines to include additional warnings.[5]
Recall of defective BD Alaris PC Unit infusion pumps
In mid-September 2020, Becton Dickinson began recalling defective BD Alaris PC Unit infusion pumps that inject too many drugs. The recall is classified as class I, that is, the use of defective devices can threaten the patient's life. One patient is known to have already suffered a serious injury potentially related to a defective infusion pump. In general, 1,186 complaints were received in connection with this problem.
The recall concerns the BD Alaris PC Unit Model 8015 and a number of keyboard replacement kits. During the site inspection, it became known that these models often do not respond to keystrokes. In this case, the infusion pump continues to inject the drug according to the programmed mode, and users cannot make changes to the program. The jamming of the keys is not accompanied by an alarm, which means that medical workers can only learn about the problem at a critical moment.
BD reported that the pump malfunction could also delay the start of the infusion. In patients receiving life-critical drugs, such delays can have serious consequences. As of the end of July 2020, BD had received one report of a serious injury. In this case, a malfunction of the pump almost led to the death of the patient.
The company's guidelines say healthcare professionals can continue to use the devices until BD replaces the keyboards. In the event that the keyboard stops responding to presses, BD advises health workers to stop using the device and report a malfunction. The manufacturer believes that the cause of the malfunction of the device is "liquid ingress." BD therefore asked maintenance staff to follow usage instructions to reduce the risk of fluid ingress.[6]
2019: Alaris Pump Model 8100 defective infusion pumps recall
In mid-July 2019, Becton Dickinson recalls defective Alaris Pump Model 8100 infusion pumps that administer drugs even after a shutdown. The recall was initiated after several reports of serious adverse events with a drug overdose.
Alaris infusion pumps have been withdrawn from the market due to the likelihood of faster than expected drug administration (overdose hazard) or unintentional administration occurring even when the pump is shut down. Becton Dickinson determined that the cause was a manufacturing defect - it turned out that the silicone segment of defective pumps has a heterogeneous thickness and does not completely overlap the tube when the device is turned off. Such a defect can cause serious adverse health effects for patients, including leading to death. Regulators attributed the problem to the highest hazard class. The recall included devices released from May 1, 2016 to March 31, 2019, the total number of which exceeds 150 million.
The company urges paramedics to immediately check the inventory for defective models and dispose of defective devices. It is recommended that this information be disseminated to hospital staff to avoid serious injury. If adverse events involving the use of defective models develop, it is recommended to notify the manufacturer immediately by reporting the model code and batch number. In addition, adverse events can also be reported through the MedWatch program. FDA
Becton Dickinson provides replacement defective products, but encourages paramedics to notify a contact person of receipt of notification even if the hospital does not have defective infusion pumps.[7]
Notes
- ↑ BD inks $85M settlement over Alaris defect disclosure claims
- ↑ Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
- ↑ BD issues vulnerability warning for Alaris infusion monitoring software
- ↑ Another BD Alaris infusion pump recall is Class I
- ↑ Alaris remediation could cost BD up to $244M
- ↑ Another BD Alaris recall pegged Class I event by FDA
- ↑ Becton Dickinson recalls infusion sets on safety issue
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