How to Mitigate Your Organization’s Exposure with Medigate
On February 4th of this year, Becton Dickinson (BD)/CareFusion 303 issued a “Medical Device Recall Notification” to address “specific software issues with the BD Alaris System™ System Infusion Pumps. March 6th, the FDA classified it as a Class I recall, due to the fact the “use of these devices may cause serious injuries or death”.
This blog contains information to help healthcare delivery organizations understand the scope of their exposure and ways in which they can mitigate the risk.
Background on the Alaris recall.
According to BD/CareFusion 303, the recall of Alaris Infusion Pump System and Modules is due to “multiple system errors, software errors, and use-related errors.”
For modules with software version 9.33 or earlier look for:
- Issue 1: Software errors related to System Error Code 255-XX-XXX
- Issue 2: Delay Options programming
- Issue 3: Low Battery Alarm Failure
- Issue 4: Keep Vein Open (KVO) / End of Infusion alarms priority
- Issue 5: Use Errors related to Custom Concentration programming
For modules with software version 12.1.0, look for:
- Issue 1: Low battery alarm failures
- Issue 2: Keep vein open (KVO)/ “End of Infusion” alarm priority
- Issue 3: Use errors related to custom concentration programming
- Issue 4: KVO Rate Not Available When Using Delay Options programming
Scope of the BD recall.
According to BD, the Alaris systems are used in the care of 70% of patients who are on infusion pump therapy. Estimates place the number of systems at risk is close to 775,000, as reported by BD, including:
- Alaris System Pump Modules
- Lot Numbers: All Lots of affected Models
- BD Alaris System PC Unit Model 8000, software versions 9.5 and prior
- BD Alaris System PC Unit Model 8015, software versions 9.33 and prior, and software version 12.1.0
- BD Alaris Pump Module Model 8100, software versions 9.33 and prior, and software version 12.1.0.
- Alaris Syringe Module Model 8110, software versions 9.33 and prior, and software version 12.1.0
- Alaris PCA Module Model 8120, software versions 9.33 and prior, and software version 12.1.0
- Distribution Dates: Alaris PC units with software version 9.33 and older – July 2004 to October 31, 2019; Alaris PC units with software version 12.1.0 December 18, 2019 to January 23, 2020
What can be done to mitigate the risks of the BD Alaris recall.
The company reported on a call with investors in November it was planning upgrades to the pump systems, including changes to alarm prioritization and optimization. CFO Chris Reidy said BD was “in discussions with the FDA about the timing of these upgrades and the possibility of bundling them with a new software version release.” BD will contact affected customers to initiate the scheduling process for the software update when it becomes available.
Until then, BD recommends customers inspect and monitor “both Priority 1 and Priority 2 pumps as soon as feasible.” Two webinars led by BD experts are offered: Briefing on BD Alaris™ System Commitment to Safety and a training on BD Alaris™ Medication Safety Program for Custom Concentration.
How Medigate can help address the BD Alaris recall.
The Medigate platform can help healthcare organizations identify and locate all of the affected devices quickly. The platform is already flagging the following affected devices with alerts:
- BD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
- BD Alaris™ System PC Unit Model 8015, software versions 9.33 and prior
- BD Alaris™ Pump Module Model 8100, software versions 9.33 and prior
- Alaris™ Syringe Module Model 8110, software versions 9.33 and prior
- Alaris™ PCA Module Model 8120, software versions 9.33 and prior
Finding them in the dashboard is simple:
- Go to the Alerts tab
- Search BD-15270
- Review each affected device and its location in the facility
- Click on the recall to see more details about the recall.
We will continue to monitor the situation and update this blog to keep you up to date on any new developments or recommendations.
If you’d like us to show you how we can identify your devices quickly, contact us today or hit the chatbot with specific questions. We’re here to help.