TOPIC: Alaris Infusion Pumps Serviced by Tenacore: Class I Recall – Due to Possible Cracked or Separated Bezel Repair Posts
AUDIENCE: Patient, Health Professional, Risk Manager
ISSUE: 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.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: 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.
RECOMMENDATIONS: 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.
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