Damaged Alaris infusion pumps linked to two serious injuries as FDA updates safety instructions
The U.S. Food and Drug Administration (FDA) said it is aware that Becton Dickinson has sent a letter to all known customers, warning them about a potential danger associated with a line of infusion pump modules. If the units are dropped or jarred, components may become damaged without the user noticing. This can cause the infusion system to deliver an inadequate amount of fluids, or too much—or possibly stop it from calibrating properly.
The modules subject to what’s being referred to as a “recall” are part of the Alaris brand. While this alert has been given the FDA’s most serious designation, a set of updated use instructions is sufficient for the modules to be safely used. The agency said there is no need to return the units and they can still be used for patient care—assuming they are not damaged.
The serious nature of the warning comes from the high risk infusion system malfunctions pose if not addressed. Too much of a drug, or not enough, can be fatal to a patient. To date, there have been two severe injuries associated with this issue but no deaths.
Becton Dickinson sent a letter to supply houses and providers in possession of the Alaris pump modules on Sept. 22; whereas the FDA sent out its own notice about the recall last week.
What devices are subject to this safety alert?
Anyone in possession of one of the Becton Dickinson devices on the below chart will need to take heed of corrected operational instructions in order to ensure the infusion modules are safe to use.
Next steps
If any of the above Alaris pump modules or components have been dropped or “severely jarred,” the FDA and Becton Dickinson said they should be isolated immediately, until the entire unit can be “thoroughly tested and inspected by qualified service personnel” to ensure there is no damage.
Per the instructions that came with the modules, this qualified individual is typically a biomedical engineer who is very familiar with the internal workings of these machines.
To facilitate these safety inspections, the following warning has been added to the official instructions for use and should be posted near the devices:
“To ensure that the BD Alaris Infusion System remains in good operating condition, visually inspect the system before each use. Check all visible surfaces and moving parts on the devices. If you observe damage in any way or find the device does not function as expected, return it to biomedical engineering for repair.”
Those with questions are invited to contact Becton Dickinson technical support by calling 888-812-3229. Both the FDA and the company ask that the recall notice with corrected use instructions be shared. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.