Manufacturer Recalls: BD Alaris Systems with Updates

Manufacturer Recalls: BD Alaris Systems with Updates

If you have not read our previous BD Alaris Systems recall posted in May 2020, please click here to read it.

This is an update on the BD Alaris Systems recalls since May:

From BD:

BD is initiating a voluntary recall for the BD Alaris Infusion Pump System concerning four hardware

situations that require your attention and actions. These hardware situations are independent

from the following previously reported activities:

On February 4, 2020we initiated a recall of the BD Alaris™ System software, including onefor the low battery alarm failures.

On April 15, 2019, we initiated a recall of the BD Alaris™ Pump Module bezel assembly.

On February 14, 2020, we notified customers that we are limiting distribution of our pumps

to facilities that provide certification of medical necessity.

The Issues:

The information outlined in this letter does not change the overall recall strategy; however, this

letter identifies four new hardware situations that require your attention and actions.

The four hardware situations are as follows:

Situation 1: Damaged Inter-Unit Interface (IUI) Connectors – Damaged IUI

connectors may lead to interruption of communication or power between PC Unit and

modules. This situation could result in an infusion that stops with an alarm on the

PC Unit and an interruption of therapy or monitoring. High-risk patient populations

who are receiving high-alert IV medications are at the greatest risk of harm. For these

high-risk patients, interruptions of therapy potentially can cause serious injury or death.

Situation 2: Broken elements on Alaris™ Pump Module platen - A broken upper

hinge post, lower hinge, and membrane frame on the Alaris™ pump module may prevent

the device from delivering an accurate amount of fluid, which may result in an over

infusion, free-flow conditions, or under infusion. High-risk patient populations who

are receiving high-alert IV medications are at the greatest risk of harm. For these high-risk

patients, over infusion, free-flow conditions, or under infusion of therapy potentially can

cause serious injury or death.

Situation 3: Improperly secured PC unit Battery - If the battery is not properly

secured to the Alaris™ PC Unit that is running on battery power, the system may experience

a power loss with a prolonged, non-silenceable alarm. Power loss may result in an

interruption of patient therapy or monitoring. High-risk patient populations who are

receiving high-alert IV medications are at the greatest risk of harm. For these high-risk

patients, interruptions of therapy potentially can cause serious injury or death.

Situation 4: Dim Segment - The LED display on the module may have some segments

that appear dim, and therefore, the number may not be clearly displayed. The purpose of

this display is to provide the clinicians with infusion or patient monitoring values associated

with the type of module. If this dim segment is discovered during clinical use, it may cause

slight user confusion or inconvenience when noticed.

Affected BD Products include:

- Alaris™ System PC Unit Model 8000

- Alaris™ System PC Unit Model 8015

- Alaris™ Pump Module Model 8100

- Alaris™ Syringe Module Model 8110

- Alaris™ PCA Module Model 8120

- Alaris™ EtCO2 Module Model 8300

- Alaris™ SpO2 Module Model 8210 and Model 8220

- Alaris™ Auto ID Module Model 8600

BD Contact Information:

Contact Contact Information Areas of Support
BD Customer
Advocacy
Phone: 888-812-3266
Phone Hours: 7AM-5PM PT Mon-Fri
Email: customerfeedback@bd.com
Product Complaints
Training
Resources
BD has established a website for easy access to
training resources and to support customers with
this recall.
End-user training outlined in this
notification
Clinical &
Pharmacy
Support
Center
Phone: 858-617-1316
Phone Hours: 5AM-5PM PT Mon-Fri
Email: GMB-AlarisMedSafetyProgram@bd.com
Clinical or Pharmacy related questions
BD Recall
Support
Center
Phone: 888-562-6018
Phone Hours: 7AM-4PM PT Mon-Fri
Email: SupportCenter@bd.com
Recall Related Questions
Technical
Support
Phone: 888-812-3229
Phone Hours: 6AM-5PM PT Mon-Fri
Email: DL-US-INF-TechSupport@bd.com
Technical Questions

US Med-Equip's Solution:

All BD Alaris devices affected in the recall will be removed from rent and pulled off the shelves in order to fix the software problem. Until further notice, we will be vigilantly watching out for any incoming and outgoing units to ensure that they are working properly before putting them back out on rent. If you have an affected BD Alaris device from USME, please email QA@usmedequip.com to place your report and get your unit replaced.

The USME Mission

Our Mission is to promote the healing process by providing smart solutions for our partners and the patients they serve.

We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.

For any further questions regarding equipment recalls, please email QA@usmedequip.com

About US Med-Equip

US Med-Equip (USME) partners with top hospitals across the nation to provide the highest quality movable medical equipment for patients in their care. USME, an Inc. 5000 Fastest Growing company, supplies quality-certified equipment rented, sold, maintained and managed using the latest technology to help healthcare providers focus on their patients’ healing.