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 Pumps serviced by Tenacore
- Models: Model 8100
- Serial Numbers: Please See Link Below.
- Distribution Dates: July 10, 2020 to February 18, 2021
- Devices Recalled in the U.S.: 474
- Date Initiated by Firm: February 25, 2021
The Alaris Pump is used to deliver fluids such as medications, nutrients, solutions, blood, and other therapies into a person’s body in controlled amounts. Bezel posts by Tenacore are used to service and repair infusion pump modules.
Reason for Recall
Tenacore is recalling the Alaris Pump because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. The separation of one or more bezel repair 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
- device leaking
- device component burning or smoking
- power supply failure or malfunction
If this device issue occurs, this could cause serious patient harm.
There have been two complaints reported about this device issue. No injuries or deaths have been reported.
Who May be Affected
- Health care providers using the affected Alaris Pump serviced by Tenacore with a Bezel Assembly
- Patients who require care using the affected Alaris Pump serviced by Tenacore with a Bezel Assembly
What to Do
On February 25, 2021, Tenacore sent a Field Safety Corrective Action letter to all affected customers. The letter requested that customers take the following actions:
- Review the serialized list of potentially impacted pumps.
- Immediately quarantine the potentially affected devices.
- Inspect the potentially affected devices to determine if the impacted bezel repair part is installed.
- Contact Tenacore to schedule bezel repair replacement. The impacted bezel repair part must be replaced before the pump can be returned to service.
- Complete and return the customer response form.
The letter also requested device dealers and distributors:
- Share the Field Safety Corrective Action letter with customers who may have received the potentially impacted pumps.
Customers who have questions about this recall or would like to schedule replacement of impacted parts should contact Tenacore’s Quality Assurance at 714-371-9919 or by emailing Quality@Tenacore.com.
Full List of Affected Devices
- Please See Link Below.
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.