In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type of plastic material. BD conducted an investigation and determined that the bezel manufacturing process resulted in weakened plastic. Over time, further weakening of the plastic has the potential to lead to separation of the bezel posts, as well as other damage to the bezel, which may result in free-flow, over-infusion, under-infusion or interruption of infusion.
On April 15, 2019, BD instructed customers to inspect all pumps included in this recall action during the annual preventive maintenance, and if damage is found, the pump should be removed from service and BD should be contacted. BD subsequently revised its recall notification to state “that until the bezels affected by this recall are replaced, customers should inspect both Priority 1 and Priority 2 pumps as soon as feasible.”
Alaris Infusion Sets
In a recall notification sent on May 6, 2019, BD confirmed that an incomplete occlusion can occur on the pumping segment of certain Alaris Pump Model 8100 infusion sets. This is caused by a variation in the wall thickness of the pumping segment of the affected infusion sets. Use of the affected products has the potential to lead to unintended delivery of medication when the pump module is not in running status, flow inaccuracies through the pumping cycle process resulting in an over-infusion, and the potential for serious patient injury depending on the type of medication that is being delivered. Instructions for customers, including a full list of affected product codes, lot numbers and expiration dates are included on the BD website at https://www.bd.com/en-us/support/recall-notifications/recall-notification-alaris-pump-infusion-sets. BD instructed customers to destroy all Alaris Infusion Sets affected by this recall.
On September 1, 2017, BD announced that it had identified an issue with the Alaris Pump module. BD received reports of increased or decreased flows that have occurred in pumps with mechanical assemblies manufactured with the date code October 2011 and November 2011. These mechanical assemblies were used in the Alaris Pump modules manufactured between November 4, 2011 and March 11, 2012 and serviced between November 4, 2011 and March 14, 2012.
BD identified the component of the Alaris Pump module mechanical assembly of concern is the bezel assembly, specifically the bezel posts. The affected mechanical assembly may have separation of one or more posts that connect the mechanism frame to the bezel assembly. There are 6 posts located on the innermost side of the mechanical assembly, which are not visible from the exterior of the pump.
BD warned that the separation of one or more posts that connect the mechanism frame to the bezel assembly may prevent the device from delivering an accurate amount of fluid flow through the pumping cycle resulting in an over or under infusion condition. In addition, it may prevent the pump from alarming for an upstream or downstream occlusion condition. The separation of one or more posts are not visible to the end user. An over or under infusion may lead to injuries requiring medical intervention.
BD stated at that time that it has assessed the risk of this issue and determined that the affected product can still be used until it is remediated. However, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. BD instructed the use of non-affected devices in high risk areas if possible and to consider having additional devices as back up until affected devices are remediated.
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