The United States Food and Drug Administration (FDA) has released an updated correction notification for BD Alaris pump modules. These devices, used in the administration of fluids to patients, are now subject to strict updated usage guidelines due to potential safety risks. Clinicians, quality teams, and regulatory professionals must take note of these changes as noncompliance could lead to serious health outcomes.
What Changed?
On October 17, BD issued safety updates regarding its Alaris Pump Modules after identifying risks associated with devices that have been dropped or severely jarred. The company emphasized that physical impacts can cause unseen damage to critical internal components, such as the bezel assembly, which serves as the mechanical backbone for the pump mechanism.
This type of damage may lead to device malfunctions, including inaccurate fluid delivery. Specific consequences include under-infusion, over-infusion, unregulated flow, or failure to calibrate. These malfunctions pose risks of serious injury or even death depending on drug type, patient condition, and infusion rates.
Who Is Affected?
This correction affects U.S.-based facilities utilizing BD Alaris System modules. Health professionals are advised to discontinue the use of any pump module that has been dropped or subjected to a severe physical shock. Facilities that purchased, rented, or transferred these devices must ensure all personnel—including transport and environmental services teams—are adequately trained on the updated precautions.
Safety Guidelines for BD Alaris Pump Modules
Inspection and Handling
According to BD’s recommendations and the FDA guidelines, facilities must inspect pump modules for visible damage prior to use. Devices showing wear or malfunction should be removed from service and sent to qualified biomedical engineering teams for thorough testing.
The BD Alaris Infusion System with Guardrails Suite MX User Manual provides detailed warnings and cautions on device handling. The manual is accessible through BD’s Service and Support Portal. Users are advised to visually inspect the system before each use and segregate damaged equipment immediately.
Steps to Ensure Safety
- Segregate and label any device that has been dropped or jarred.
- Send the affected device for inspection by biomedical engineering professionals as outlined in the user manual.
- Ensure all clinical and non-clinical staff are trained to identify and remove compromised devices.
- Distribute the BD safety reminder notice across relevant departments.
- Use only BD-certified rental services for obtaining new or replacement devices.
- Complete the Customer Response Form provided by BD to acknowledge receipt of this notification and specify if impacted devices are in use at your facility.
Why This Matters
The modular BD Alaris Infusion System is vital for the administration of fluids in healthcare settings, including intravenous, subcutaneous, intra-arterial, and epidural routes. Any failure in these modules due to physical damage undermines the accuracy needed for safe drug delivery. With reports of two physical injury cases linked to this issue, the FDA has classified the correction as its most serious recall category.
The unique device identifier (UDI) system was highlighted as an essential tool for tracking affected products and analyzing device-related adverse events.
Conclusion
In light of this FDA correction, all affected organizations must act swiftly to revise their handling protocols for BD Alaris Pump Modules. By following the newly issued guidelines, healthcare teams can reduce risks, prevent adverse safety events, and ensure patient protection.
Disclaimer
This article is intended as informational guidance for clinical, regulatory, and quality professionals. It does not constitute legal or medical advice. Readers are encouraged to consult the FDA-announced letter and BD advisories for authoritative details.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-becton-dickinson-updates-use-instructions-bd-alaris-pump-issue