PRA number
2021/18896
Published date
Product description
T34 Syringe Pump
All serial numbers
ARTG 131232
(REM Systems Pty Ltd - Infusion pump, syringe)
For the provision of small dose infusion therapy, the T34 Syringe Pump gradually administers small precise amounts of fluid and/or medications to a patient.
All serial numbers
ARTG 131232
(REM Systems Pty Ltd - Infusion pump, syringe)
For the provision of small dose infusion therapy, the T34 Syringe Pump gradually administers small precise amounts of fluid and/or medications to a patient.
Reasons the product is recalled
The voltage of the 9V/6LR61 battery may drop prematurely or earlier than expected in T34 2nd and 3rd edition devices.
This may cause an interruption to the infusion, following events of:
1. Premature 'low battery' or 'end battery' alarms
2. Unexpected pump shut down with or without alarm.
Battery brands/lots that have lower and more stable internal resistance are not likely to cause significant voltage dips and therefore not likely to trigger early low/end battery alarms or pump shut down.
This may cause an interruption to the infusion, following events of:
1. Premature 'low battery' or 'end battery' alarms
2. Unexpected pump shut down with or without alarm.
Battery brands/lots that have lower and more stable internal resistance are not likely to cause significant voltage dips and therefore not likely to trigger early low/end battery alarms or pump shut down.
The hazards to consumers
If there is an interruption to the infusion, or the pump shuts down unexpectedly, this could result in the patient receiving insufficient delivery of medication or fluids, which can lead to serious health complications.
What consumers should do
REM Systems will contact affected customers in writing.
Consumers are requested to take the following actions for devices currently in clinical use:
1. Continue use of the device with 9V/6LR61 type batteries as per the Directions For Use (DFU) instructions;
2. As a precaution, always have a spare set of high quality batteries;
3. Be mindful that battery life may be affected by factors such as temperature and battery manufacturer;
4. Maintain infusion monitoring and best clinical practices to detect and react to system alarms as per DFU instructions; and
5. Report without delay any device complaint including events of early/premature battery alarms, or any instances of unexpected pump shut down without alarm.
For further information, contact REM Systems Customer Service by phone on 1800 737 222
Consumers are requested to take the following actions for devices currently in clinical use:
1. Continue use of the device with 9V/6LR61 type batteries as per the Directions For Use (DFU) instructions;
2. As a precaution, always have a spare set of high quality batteries;
3. Be mindful that battery life may be affected by factors such as temperature and battery manufacturer;
4. Maintain infusion monitoring and best clinical practices to detect and react to system alarms as per DFU instructions; and
5. Report without delay any device complaint including events of early/premature battery alarms, or any instances of unexpected pump shut down without alarm.
For further information, contact REM Systems Customer Service by phone on 1800 737 222
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.