Published: 26 March 2016

Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Apex e-chamber spacer device - user issues with valve and round mouthpiece

23 May 2016

Monitoring finishes 26 November 2016

Medsafe has received a number of reports of issues relating to the use of the Apex e-chamber spacer device. The main issues described are:

• the valve in the e-chamber is not opening as intended
• swing gate valve is ineffective unless held in exactly the correct position which is very difficult when using the device with children
• difficulties encountered using the round mouthpiece which allows some of the spray to escape

Products Affected

Apex e-chamber spacer

The e-chamber spacers are used to help overcome the co-ordination problems people may have when using inhalers.

Additional Information

e-chambers are intended to slow the delivery of medication which then allows greater delivery of medication to the lungs.

These spacer devices are funded by PHARMAC.

Regulator Actions

Medsafe is continuing to monitor the rate and pattern of occurrence of these issues.

Reporting

Consumers and healthcare professionals are encouraged to report problems with medical devices to Medsafe to devices@health.govt.nz.

When reporting an event relating to this type of device, Medsafe requests that the reporter be specific about the issues experienced with the device and the consequences/ outcome, if any, of the issue.

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.