Health Products

BD Alaris™ Syringe Pumps

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: BD Alaris™ Syringe Pumps
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
BD Alaris GH Plus Guardrails Syringe PumpMore than 10 numbers, contact manufacturer.8002MED01-G
BD Alaris GH Plus Guardrails Syringe PumpMore than 10 numbers, contact manufacturer.8002TIG01-G
BD Alaris GH Plus Guardrails Syringe PumpMore than 10 numbers, contact manufacturer.8002TIG03-G
BD Alaris PK Plus Syringe PumpMore than 10 numbers, contact manufacturer.8005PK201
BD Alaris PK Plus Syringe PumpMore than 10 numbers, contact manufacturer.8005TIG01
BD Alaris PK Plus Syringe PumpMore than 10 numbers, contact manufacturer.8005TIG03
BD Alaris CC Guardrails Syringe Pump With Plus SoftwareMore than 10 numbers, contact manufacturer.8003TIG01-G
BD Alaris CC Guardrails Syringe Pump With Plus SoftwareMore than 10 numbers, contact manufacturer.8003TIG03-G
BD Alaris CC Guardrails Syringe Pump With Plus SoftwareMore than 10 numbers, contact manufacturer.8003MED01-G

Issue

BD has identified through an internal investigation that the BD Alaris™ syringe pumps may develop a mechanical anomaly on the linear potentiometer if the device is not stored in the correct position. The syringe plunger moves along the linear potentiometer component during infusion. This is an internal component and not readily visible to the clinical user. If this anomaly occurs, it can lead to incorrect sensor readings, which may trigger error codes PL3, PL8, or PL9. These PL error codes are an intentional design feature that notify the clinical user that the syringe pump has detected an internal malfunction and can occur for a number of reasons. The PL3/PL8/PL9 error codes result in the syringe pump issuing an error message along with a red illuminated beacon, and a high priority alarm tone. If an infusion is in progress, it will stop. The error code will be displayed on the syringe pump as <error code and message>, see below image example of a PL9 error code.

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