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 Infusion Pump Module Model 8100 Front Bezel, purchased and/or installed by Pacific Medical Group (DBA Avante Health Solutions)
- Models: Alaris Model 8100
- Serial Numbers: Please See Recall Database Entry Link Below.
- Distribution Dates: July 10, 2020 to February 18, 2021
- Devices Recalled in the U.S.: 2,452
- Date Initiated by Firm: March 24, 2021
The Alaris Infusion Pump Module Model 8100 is used to deliver fluids such as medications, nutrients, blood, and other therapies into a person’s body, in controlled amounts. The front bezel component is critical to the proper performance of the infusion pump. Bezel posts from Pacific Medical Group are used to service and repair infusion pump modules.
Reason for Recall
Pacific Medical Group (DBA Avante Health Solutions) is recalling the affected products and devices because the front bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. The separation of one or more bezel posts may result in:
- free flow of fluids to patient
- over delivery or under delivery of fluids delivered to a patient
- interruption of fluids delivered to a patient
There have been 62 complaints reported about this device issue and one death may have been related to this recall. No other injuries have been reported.
This recall is related to Tenacore’s recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly.
Who May be Affected
- Health care providers using the Alaris Pump Module Model 8100 with an affected bezel
- Patients who require care using the Alaris Pump Module Model 8100 with an affected bezel
What to Do
On March 24, 2021, Pacific Medical Group (DBA Avante Health Solutions) sent a Medical Device Recall Notification to all affected customers. The letter requested that customers take the following actions:
- Identify if you have affected product.
- Remove affected devices from clinical use and immediately quarantine them until the impacted parts can be returned to Pacific Medical Group.
- Contact Customer Service at 800-449-5328 or by email at email@example.com to start the process for replacement.
- Once returned to customer service, the affected device will be evaluated, inspected, and replaced by Avante Health Solutions and then returned to the customer.
- If you have resold or distributed the affected product, please forward this notice to your customers.
- Complete and return the customer acknowledgement form.
Customers who have questions about this recall should contact Avante Health Solutions customer service at 800-449-5328 or by emailing firstname.lastname@example.org.
Full List of Affected Devices
- Please See Recall Database Entry Link Below.
- Medical Device Recall Database Entry
- Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.