Becton Dickinson (BD) has issued a recall for their Alaris Pump Module Model 8100 manufactured between April 2011 and June 2017 and any products using affected FR-110 plastic. The FDA has classified this manufacturer initiated, voluntary recall as a Class I recall. Meaning the use of affected devices could lead to injury or death. At the time of the official medical device recall notification, April 15, 2019, BD had received 364 reports of malfunctioning bezels. Of these 364 reports 12 resulted in injury reports, however, no reports indicated lasting harm or death.
What Products are Affected?
Products affected include any equipment or parts using the defective bezels made with FR-110 plastic. This includes:
- Alaris Pump Modules Model 8100
- Manufactured between April 2011 and June 2017.
- Priority 1 - Manufactured between April 2011 and October 2014.
- Priority 2 - Manufactured between November 2014 and June 2017.
- Alaris Pump Modules serviced with LVP Mechanism Sub Assembly
- P/N #10942012, #49000007, #49000203.
- Alaris Pump Module Bezel Kit Assembly
- P/N #10964559, #49000204.
Pumps are categorized as Priority 1 or Priority 2 depending on the manufacturing date. Of the 12 injury reports, all 12 pumps were manufactured between April 2011 and October 2014. BD has categorized pumps manufactured during these dates as Priority 1. Pumps manufactured after those dates, November 2014 to June 2017, are categorized as Priority 2 "due to their reduced likelihood of weakened plastic leading to cracked bezel issues compared to the Priority 1 pumps." The recall does not include pumps or bezels manufactured after June 2017. In June 2017 BD began using a different type of plastic material called Valox. Valox bezels have been extensively tested and have had no issues to date.
Why Was it Recalled?
In their investigation of the 12 injury reports, BD identified a specific type of plastic used in the production of their bezels, FR-110, that may have had issues in manufacturing, making the plastic weak or prone to collapsing. According to the FDA recall notice, the silicone segment of the affected administration set has a non-uniform wall thickness that can lead to tubing collapse and "can contribute to a failure to fully occlude the tubing." At the time of this blog's publication, BD's website stated the following, "BD confirmed that infusion sets affected by this recall have a variation in the wall thickness of the pumping segment and therefore may not be fully occluded by the pump."
So what does this mean? BD concluded that the issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is in use.
What Should Customers Do?
BD issued their notice of recall in May of 2019 and stated that they would begin contacting customers with Priority 1 pumps in June of 2019 to initial scheduling of inspection for these pumps. Once Priority 1 pumps have been addressed, BD will contact customers to schedule replacement of bezels in Priority 2 pumps. BD recommends customers confirm the type of model Alaris pump they have. If it is a model 8100 manufactured between April 2011 and June 2017, BD recommends the bezels be inspected and offer support in scheduling a bezel replacement, free of charge under this recall. If you need to contact BD in regards to this recall, you can visit their dedicated website for recall support at http://alaris.bdproductnotice.com or by calling the following numbers:
- Regional Customer Quality: (888) 237-2762. Opt 3, Opt 2 - Monday to Friday 8 AM to 5 PM (CT).
- General questions or Customer Advocacy: (888) 812-3266 7 AM to 5 PM (PST).