| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00245-1 |
| Product Name/Description |
T34L and NIKI T34 Ambulatory syringe pumps
Caesarea Medical Electronics T34L Syringe Pumps
Catalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ,
CE-100-109PSLAU
All Pumps and Pump Housings manufactured from 2013 onwards
Caesarea Medical Electronics NIKI T34 Syringe Pumps
Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS
All Pumps and Pump Housings manufactured from 2013 onwards
ARTG Number: 131232 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Caesarea Medical Electronics (CME) has received reports of syringe pumps NIKI T34/T34L stopping and activating an alarm condition when being used in direct sunlight. If the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.
This action has been closed out on 05/04/2022 |
| Contact Information |
1800 737 222 - REM Systems |