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Safety Report: BD Alaris System - recalled due to Infusion pump may not operate as expected, USA

2 years ago •source fda.gov

Recall notice

United States

Company name: Becton, Dickinson and Company
Brand name: BD
Product recalled: Alaris System
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: August 02, 2021
Recall details: FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/ BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the company will begin remediation for the February 4, 2020 BD Alaris™ System 1 recall through a new version of software.

The February 4, 2020 voluntary recall action notified customers of the following areas where the infusion pump may not operate as expected:

- Software errors related to System Error Code 255-XX-XXX
- Delay options programming
- Low Battery Alarm Failure
- Keep vein open (KVO)/End of Infusion alarms priority
- Use errors related to Custom Concentrations Programming

Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris™ System software version 12.1.2 and associated ancillary software to remediate the affected software. Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018.

The new software, which will be available at no cost to customers, is expected to remediate the issues identified in the February 4, 2020 recall notice and provide programming, operational, and cybersecurity updates to affected devices; however, this software update has not been reviewed or cleared by the FDA. In April 2021, BD announced that the company has submitted a 510(k) submission to the FDA for the BD Alaris™ System, which is intended to bring the regulatory clearance up to date.

This submission covers all modifications to the BD Alaris™ System since its last 510(k) clearance, including updated hardware features as well as software version 12.1.2.

"Frontline clinicians continue to rely on the BD Alaris™ System to deliver medications, fluids and blood products to support the care of their patients," said Michael Garrison, worldwide president of Medication Management Solutions for BD. "This remediation is a positive step forward for our customers while the FDA reviews our 510(k) submission." The BD Alaris™ System allows clinicians to deliver medications, fluids and blood products through a single integrated platform that includes large volume pumps, syringe pumps and patient-controlled analgesia (PCA) modules for adult, pediatric and neonatal patients.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-begin-remediation-bd-alaristm-system-software

Source: FDA

#medicaldevices #recall #blood #us

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