Pacific Medical Group Recalled Alaris Infusion Pump Bezel
The Alaris Infusion Pump (Model 8100) is used to deliver fluids into a person’s body in controlled amounts such as nutrients, medications, blood, and other therapies. The bezel post is used to service and repair infusion pump modules. In order for the machine to perform properly, the front bezel component is critical.
The Pacific Medical Group is recalling the devices because the front bezel components may lead to inaccurate delivery of fluids to patients due to cracks or separation. The separation of one or more bezel posts may result in the interruption of fluids delivered to a patient, over-delivery or under-delivery of fluids delivered to a patient, or the free flow of fluids to a patient.
One death and 62 complaints have been reported about this device issue and are believed to be associated with this recall. No other injuries have been reported at this time. The Pacific Medical Group requests that customers take the following actions:
- Identify if you have an affected product.
- Complete the customer acknowledgment form.
- Remove affected devices from clinical use and quarantine them until the impacted parts can be returned to Pacific Medical Group.
- Contact Customer Service at 800-449-5328 for replacement.
- Once returned to customer service, the affected device will be evaluated, inspected, and replaced by Avante Health Solutions. The device will then be returned to the customer.
- Please forward this notice to your customers if you have resold or distributed the affected product.
This recall is related to Tenacore’s recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly:
Tenacore Recalled Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly
Tenacore recalled the Alaris Pump due to the bezel repair posts causing cracks or separation leading to inaccurate delivery of fluids to patients. No injuries or deaths have been reported. There have been two complaints reported about this device issue. Patients who require using the affected Alaris Pump serviced by Tenacore with a Bezel Assembly as well as health care provides who have used the affected Alaris Pump serviced by Tenacore with a Bezel Assembly may be affected by this recall.
Tenacore requests that customers take the following actions:
- Identify if you have an affected product by reviewing the serialized list of potentially impacted pumps.
- 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.
- This must be replaced before the pump can be returned to service.
- Complete the customer response form.
- Forward this notice to your customers who may have received the potentially impacted pumps.
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