BD
(NYSE: BDX)
issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system.
According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not affect to Alaris systems in the U.S.
Free flow as a result of this issue may result in over-infusion. Damage to the pump-based free flow mechanism may not be apparent to the user. Depending on the medication in progress at the time of the free flow, BD says it’s reasonable to expect that an imminently life-threatening situation may arise as a result of the issue.
To date, the company reports one adverse event related to the issue with its neXus V700 infusion pump.
BD reported the issue and advises that clinicians remove the infusion pumps from clinical use with immediate effect. Clinicians should also quarantine devices until the company receives further information from Medcaptain Medical Technology, the legal manufacturer. Prior to opening the door and/or removing the administration set from the pump, clinicians should ensure the roller clamp remains closed, as per the instructions in the system’s directions for use.
The company designed its Alaris neXus platform to simplify the infusion experience through IT and connectivity solutions. neXus features Guardrails safety software and Wi-Fi connectivity to protect the patient and the clinician from the consequences of medication errors for all care areas in hospitals, according to the BD website.
This marks the latest setback under the umbrella of BD Alaris infusion products.
