| TGA Action ID |
RC-2026-RN-00109-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BD Alaris Syringe Pumps and Spares Kits
Multiple products, catalogue and serial numbers |
| ARTG Number |
177501 |
| Unique Device Identifier (UDI) |
10885403485268, 10885403484704 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Specific lots of the keypad components may exhibit unintended behaviour impacting the “On/Off”, “Hold” and “Run” keys.
Specifically, the affected pumps may experience one or more of the following failure modes:
- The pump may enter “Tech Mode” autonomously during power-up.
- Keypad buttons may become unresponsive, preventing normal operation.
- A “KY1” error may be displayed, indicating a stuck key.
A faulty keypad on the BD Alaris Syringe Pump may cause delays in starting or interruptions during infusion, with the severity of harm depending on the drug type, patient condition, and duration of the interruption. Potential outcomes range from no harm to critical injury, particularly when short half-life vasoactive drugs or TIVA are involved, as these are used in high-acuity patients and can lead to hemodynamic instability or reduced anaesthesia within minutes.
To date, there have been no reported serious adverse events as a result of this problem. |
| Instructions for Customers/Users |
Actions required by Clinical Users:
- Organise for the affected Alaris Syringe pumps serial numbers to be made available for the Service Organisation for keypad replacement.
- Continue to use the Alaris Syringe pumps with their existing labelling and directions for use. In case users observe the pump presenting with the described issue, immediately remove it from service for inspection by Qualified Service Personnel. Use an alternative syringe pump in the meantime.
Reminder, as stated in the DFU for PK pumps (SKUs: PKnexus1, 8005PK201 or 8005TIG03) “if a surgical procedure is interrupted during a TCI (Target Controlled Infusion), all current pharmacokinetic / pharmacodynamic model information will be lost. Under such circumstances, switching the pump off and on and restarting the infusion whilst the patent contains a significant residual drug dose, could result in an over-infusion and therefore the pump should not be restarted in TCI mode”.
- Per good clinical practice, ensure spare infusion pumps are available in clinical areas delivering critical or life sustaining medications.
- If performing a patient transfer, assess if additional equipment, or alternative methods of medication administration, is required in case of system alarms. |
| Action Commencement Date |
10/02/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 8875 7000 - Becton Dickinson |