PRA number
2021/18967
Published date
Product description
Flocare Infinity II Enteral Feeding Pumps
Product codes: 40407 and 40408
All serial numbers
ARTG 119667
(Nutricia Australia Pty Ltd - Infusion pump, enteral feeding)
Product codes: 40407 and 40408
All serial numbers
ARTG 119667
(Nutricia Australia Pty Ltd - Infusion pump, enteral feeding)
What are the defects?
In a situation where the device is not plugged into the main power supply and when running on battery power only, the device may unexpectedly switch off without sounding the alarm to indicate a low battery charge.
This issue only affects Flocare Infinity Enteral Feeding Pumps. It does not affect any other Nutricia products.
This issue only affects Flocare Infinity Enteral Feeding Pumps. It does not affect any other Nutricia products.
What are the hazards?
If the device switches off, this could cause a delay in the feeding routine and potentially lead to dehydration and diabetic complications.
What should consumers do?
Nutricia Australia Pty Ltd will contact affected consumers in writing and advise consumers to follow the instructions in the customer letter:
1. Where possible, plug the device into the mains power during feeding therapy (e.g. during overnight feeding).
2. Fully charge the battery before operating the device without mains power (in a mobile use situation). The battery will be completely charged after approximately 6 hours.
3. If users notice that the battery must be charged more frequently than normal, please return the device to the service centre.
4. If the device is running on battery power only and users identify a significant decline in battery capacity or the device is not able to run a normal programmed therapy on a fully charged battery without hearing a low battery charge alarm, please return the device to the service centre.
For further information, contact the Nutricia at Home team by phone on 1800 884 367 or the Nutricia Clinical Care Line on 1800 060 051.
1. Where possible, plug the device into the mains power during feeding therapy (e.g. during overnight feeding).
2. Fully charge the battery before operating the device without mains power (in a mobile use situation). The battery will be completely charged after approximately 6 hours.
3. If users notice that the battery must be charged more frequently than normal, please return the device to the service centre.
4. If the device is running on battery power only and users identify a significant decline in battery capacity or the device is not able to run a normal programmed therapy on a fully charged battery without hearing a low battery charge alarm, please return the device to the service centre.
For further information, contact the Nutricia at Home team by phone on 1800 884 367 or the Nutricia Clinical Care Line on 1800 060 051.
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.