Safety Report: Becton, Dickinson, and Company BD Alaris System PC Units and Modules - recalled due to Infusion pump may not operate as expected, Franklin Lakes, New Jersey, United States

Franklin Lakes, 07417 New Jersey, United States

Company name: Becton, Dickinson, and Company
Brand name: BD Alaris
Product recalled: BD Alaris System PC Units and Modules
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: March 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and there is no change to those recall instructions.This recall, which BD announced on Feb. 4, 2020, has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers.BD initiated the voluntary recall to notify customers of five issues where the infusion pump may not operate as expected and provide corrections and mitigations to protect patient safety. The five items include: 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 Customer Concentrations Programming.
Customers should review and follow the instructions in the recall letter:bd.com/alaris-system-software-recall.As previously communicated, BD is committed to seeking clearance of a comprehensive 510(k) filing for the Alaris™ System, which will remediate the issues identified in the Feb. 4, 2020 recall notification.In the interim, BD is providing important user actions in the recall notification letter to help mitigate the potential risks until these software issues are fully remediated. BD has also created a dedicated team of clinical consultants to support training for health care providers. For more information and to review all of the available resources provided by BD, please visit: bd.com/alaris-system-software-recall.Affected ProductsBD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
BD Alaris™ System PC Unit Model 8015, software versions 12.1.0 and prior
BD Alaris™ Pump Module Model 8100, software versions 12.1.0 and prior
Alaris™ Syringe Module Model 8110, software versions 12.1.0 and prior
Alaris™ PCA Module Model 8120, software versions 12.1.0 and prior
Note that some affected devices may be branded under the CareFusion name.
Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-feb-4-2020-voluntary-recall-bd-alaristm-system-pc-units-and-modules
Source: FDA