Events

Recall of Flocare Infinity Pump and Infinity Plus Pump (enteral feeding pumps)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nutricia Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01050-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01050-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Nutricia australia has received reports from overseas where the air in line (ail) alarm functionality of the flocare infinity enteral feeding pump did not work as expected when used with a specialised modular feeding regimen.The air in line (ail) alarm functionality may not always work with mixed or reconstituted powdered nutrition. un-dissolved particles may accumulate in the enteral feeding line or form a film on the inner side of the tube, around the pump sensors, which may interfere with pump air detection algorithms. this may result in the delivery of (excess) air into the patient. if the ail alarm is used as an indicator that the reservoir is empty (therapy completed), follow up therapy may be delayed and may place critical care and volume sensitive patients at risk.To date, no ail alarm issues have been identified with the use of ready-made liquid feed tube nutrition.Nutricia is liaising with the tga to ascertain if further action needs to be undertaken.
  • Action
    Nutricia is advising that for patients where interruptions or delay in therapy could affect their health status, the AIL alarm should not be used to indicate end of dose and the DOSE setting of the Infinity pump must be used. It should be ensured 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 be administered, so as to avoid excessive air bubbles getting in the feeding line. Nutricia is also advising users to ensure mixed or reconstituted powdered nutrition is prepared and dissolved properly to avoid particles or accumulation in the feeding set potentially hampering pump performance and a normal feeding regimen. Any nutrition added into the enteral feeding line must be of a homogeneous nature and should remain homogeneous. Users must ensure that any substrate used is indicated as suitable for enteral tube feeding delivery (refer to instructions for use on nutrition / substrate added). Nutricia recommends that, where possible, patients use ready-made liquid tube nutrition, as this is developed for the delivery specifications of the pump. For more information, please see https://www.tga.gov.au/alert/flocare-infinity-enteral-feeding-pumps . This action has been closed-out on 18/05/2017.

Device

Flocare Infinity Pump and Infinity Plus Pump (enteral feeding pumps)
  • Model / Serial
    Flocare Infinity Pump and Infinity Plus Pump (enteral feeding pumps)Product Codes: 35679, 35680All Batch Numbers affectedARTG Number: 119667
  • Manufacturer
    Nutricia Australia Pty Ltd

Manufacturer

Nutricia Australia Pty Ltd
  • Source
    DHTGA