| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00873-1 |
| Product Name/Description |
Alaris Infusion pumps
Multiple Products, Catalogue Numbers and UDI's
ARTG 130389
(Becton Dickinson Pty Ltd - Infusion pump, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
The Alaris Infusion pumps may experience problems associated with a faulty keypad. These include keypad malfunctions, keypads sticking, alarms for keypads sticking or the infusion screen displaying changes without the Healthcare professional interacting with the keypad.
A faulty keypad or unexpected changes to the infusion display screen are likely to cause user concern or confusion and in the worst-case scenario, may lead to a delay to the start of infusion or an interruption of infusion if one is being delivered. The severity of harm is dependent on the drug being administered and delay length.
For the keypad problems identified there will be no change made to the programmed infusion, despite what the display may be showing. Any infusion program changes require confirmation by the Healthcare professional, which will not be possible while the key remains stuck/pressed. The only operational keys in this scenario would be the ON/OFF button and the HOLD button. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Actions for Clinical Users
· Continue to use the Alaris Infusion devices with their existing labelling and Directions for Use
· Per the Operating Precautions:
- “If this Pump behaves abnormally, remove from service and contact Qualified Service Personnel”
- “Several alarm conditions detected by this Pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly, and no alarms are operating.”
· Per Routine Maintenance Procedure: at each usage “Inspect case, keypad and mechanism for damage”
· Per the Alarms Section: If an alarm is generated with the text DO NOT USE, remove the pump from service/use
· Confirm the rate displayed on the screen matches the prescription before acknowledging and starting any infusion, per good clinical practice |
| Contact Information |
(02) 8875 7000 - BD |