| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00049-1 |
| Product Name/Description |
Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral) - All Variants
Product Codes: with prefix 8001, 8002, 8003, 8004 and 8005 (all variants)
All Serial Numbers
ARTG Number: 177501 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Based on overseas reports from a customer, BD/Carefusion identified regarding a potential risk of syringe siphonage with pumps that have a broken “plunger back plate spring” in the plunger back plate assembly. A breakage of the plunger backplate spring may allow movement of the syringe plunger within the plunger holder mechanism which could result in siphonage. In some circumstances, this may result in a clinically significant over infusion especially in neonatal and paediatric patients, or those receiving critical drugs, at low infusion rates. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion is advising users to check the age of the pump by referring to the label on the rear case and to replace the plunger backplate spring (refer to Information Notice IN0221) on syringe pumps older than three years. Clinical areas such as neonatal, paediatric and critical care, where critical drugs are delivered at lower infusion rates are to be prioritised. In the event that users see a "Check Syringe" alarm without an identifiable cause, they are requested to remove the pump from clinical use for examination by a qualified service personnel in accordance with the Alaris Syringe Pump Technical Service Manual.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9624 9033 - Carefusion Australia |