REM Systems Pty Ltd — T34 Syringe Pump
What are the defects?
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.
What are the hazards?
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 should consumers 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
Therapeutic Goods Administration is the responsible regulator for this recall.