The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Alaris Pump Module Model 8100 Bezel Assembly:
- Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 that include bezels manufactured with a type of plastic called FR-110.
- Alaris Pump Modules serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203)
- Alaris Pump Module Bezel Kit Assembly (P/N 10964559 and P/N 49000204).
- Model Number: Model 8100
- Manufacturing Dates: April 2011 to June 2017*
- Distribution Dates: April 2011 to June 2017
- Devices Recalled in the U.S.: 586,345
- Date Initiated by Firm: Ongoing since the original recall dated July 1, 2017*
* This product was initially recalled on August 9, 2017 (FDA Recall # Z-0026-2018). The firm subsequently expanded the recall on April 13, 2018 to expand the volume of product impacted. On February 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.
The Alaris Pump Module is an infusion pump that delivers fluids including medications, blood and blood products, into a patient's body in controlled amounts. The pump administers fluids via an infusion tubing set into a patient's vein or through other cleared routes of administration. There are six bezel posts that connect the pumping mechanism frame to the bezel assembly and are critical to proper performance of the pump. The device is used in hospitals and other health care facilities
1)Two pump modules with attached Alaris PC unit. 2) Pump module door open showing the front of the bezel. 3) Back side of bezel assembly highlighting the bezel posts.
Reason for Recall
The bezel posts may become cracked and separated which could lead to inaccurate delivery of fluids to the patient. From 2011-2017, the Alaris Pump Module Model 8100 was manufactured with a type of plastic called FR-110. The manufacturing process for the FR-110 plastic resulted in weakening of the plastic, which may lead to separation of the bezel post from the pumping mechanism or other damage to the bezel, such as cracking. Separation or cracking of bezel posts may lead to over-infusion, under-infusion, free-flow state, or interruption of infusion.
This recall has been associated with MDR reports, several of which are associated with serious injuries.
Who May be Affected
- Patients of all ages receiving fluids, medications, blood, or blood products using the Alaris Pump Module Model 8100
What to Do
BD CareFusion 303, Inc., issued an updated communication on July 18, 2019 to amend the customer notification letter issued on April 15, 2019, which states that BD is contacting customers affected by the recall to schedule inspection and replacement of bezel assemblies. Customers should follow the instructions in the recall notification for inspection of their pumps. Until the bezels affected by this recall are replaced, customers should inspect bezels as soon as feasible. If damage is found during the inspection, the pump should be removed from service and BD should be contacted for replacement bezels. In addition, the notification stated:
- Customers should contact the BD Support Center to coordinate training on the bezel inspection process.
- For inspection instructions, refer to Service Bulletin 621 or watch the bezel inspection training video on BD's website.
BD's website provides additional support for customers affected by this recall.
4) Bezel post with no separation (left) and bezel post with separation (right).
For general follow-up or recall related questions, please contact BD Support Center:
- Call 1-888-562-6018 (Monday-Friday, 7 a.m.-4 p.m. PST)
- Email SupportCenter@bd.com
- BD CareFusion's Recall Resources: Alaris Pump Module model 8100 bezel post separation recall
- BD Provides Update on Voluntary Recalls of Alaris Pump Module Model 8100 and Certain Alaris Pump Infusion Sets (Issued July 2019)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX to 1-800-FDA-0178.