Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes
TGA safety alert for Aurum Adrenaline 10 mL 1:10,000 pre‑filled syringes warns of label misalignment that may create the appearance of overfill, posing a risk of dosing errors and requiring cautious use.
Health professionals and consumers are advised that Medsurge Healthcare and Link Medical Products, after consultation with the TGA, have issued safety alerts regarding Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes.
Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes are used in cardiopulmonary resuscitation (CPR) for management of cardiac arrest.
It has been identified that there is a misalignment of the label on Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes, which have been supplied to hospitals and health services in Australia by Medsurge Healthcare and Link Medical Products. The pre-filled syringes were supplied under special provisions of the Therapeutic Goods Act 1989 because of a shortage of adrenaline mini-jets.
The misalignment means the label indicating the dose is too close to the end of the barrel. Each syringe contains the correct dose, but it will appear that there is more medicine in the syringe than there should be (see image below). As a result, there is a risk of incorrect dosing.
Syringes from affected batches should be used with caution in adults and should not be administered to children.
The affected batch numbers supplied by Medsurge Healthcare are:
- 5000894
- 5000902
- 5000911
- 5000925
The affected batch numbers supplied by Link Medical Products are:
- 5000879
- 5000892
Additionally, three more batches are in the process of being supplied by Link Medical Products. The affected batch numbers are:
- 5000959
- 5000925
- 5000911
Information for consumers
Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes are used in very specific circumstances, such as in hospital settings, and only by health professionals.
All hospitals that have been supplied syringes from affected batches, as well as the relevant State and Territory health departments, have been contacted and notified of this issue.
Information for all health professionals
Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes from affected batches should be used with caution in adults and should not be administered to children.
While it may appear that there is over-fill of the syringe, the dose is correct. When giving to an adult, do not expel what appears to be excess before administration.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.