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:
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 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 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|
Phone Hours: 7AM-5PM PT Mon-Fri
BD has established a website for easy access to
training resources and to support customers with
End-user training outlined in this
Phone Hours: 5AM-5PM PT Mon-Fri
|Clinical or Pharmacy related questions|
Phone Hours: 7AM-4PM PT Mon-Fri
|Recall Related Questions|
Phone Hours: 6AM-5PM PT Mon-Fri
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.