Nutricia Advanced Medical Nutrition Australia & New Zealand — Flocare Infinity Enteral Feeding Pumps

flocare-infinity-enteral-feeding-pumps-01

Identifying features

Affected product codes: 35679, 35680
ARTG number: 119667

What are the defects?

Nutricia Australia has received overseas reports of the Flocare Infinity enteral feeding pump 'air in line' (AIL) alarm not always working when used with mixed or reconstituted powdered tube feeds. It is believed that undissolved particles can accumulate in the feeding line or form a film on the inner side of the tube around the pump sensors, which can interfere with the pump's air detection function.

What are the hazards?

If this occurs, it may result in the delivery of excess air into the patient's stomach with resulting discomfort and/or vomiting. If the AIL alarm was being used as an indicator that the reservoir was empty (i.e. feeding was completed), follow-up therapy might be delayed. This delay could place critical care and volume-sensitive patients at risk.

What should consumers do?

If you or somebody you provide care for uses a Flocare Infinity pump please be alert to the issue.

If you use mixed or reconstituted powdered nutrition, Nutricia Australia recommends the following:
•The 'dose' setting should be used and programmed, rather than relying on the AIL signal alone. When the required volume or dose has been delivered, an 'end of dose' message will appear on the screen and the pump will beep, after which the carer can take action. Do not mute the audio alarm indicating 'end of dose' in these instances. ◦When programming the 'dose' setting, the AIL alarm will remain functional.
◦Ensure that the volume of nutrition in the container is greater than the volume that is actually needed (i.e. more than the set dose) to prevent excessive air bubbles in the feeding line.

•Ensure the mixed or reconstituted powdered nutrition is prepared and dissolved properly to avoid particles accumulating in the feeding set, potentially hampering pump performance and a normal feeding regimen.

Nutricia Australia recommends that, where possible, patients use ready-made liquid tube nutrition, as this is developed for the delivery specifications of the pump.

If you have any further questions or concerns, contact your health professional or Nutricia Australia on 1800 060 051 or email nccl@nutricia.com.

Supplier
Nutricia Advanced Medical Nutrition Australia & New Zealand
Where the product was sold
Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category