Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom has posted a medical device safety alert concerning PARI SOLE N / PARI SOLE N Tracheo inhalation devices, manufactured by PARI GmbH. The affected devices are identified as follows:

• PARI SOLE N Set, item number: 025G2000
• PARI SOLE N, item number: 025G2100;
• PARI SOLE N Set – TRACHEO, item number: 025G2050;
• PARI SOLE N TRACHEO, item number: 025G2150;
• PARI SOLE N nebuliser, item number: 025G2003

The manufacturer has received a small number of complaints regarding a faulty temperature gauge on the PARI SOLE N / PARI SOLE N Tracheo inhalation device.
If liquid were to get into the lower section of the nebuliser, the temperature gauge could be damaged. If this were to happen, the heating function might not switch off automatically and consequently the inhalation solution and the aerosol generated would become very hot. This could result in the user's mucous membrane being scalded during an inhalation session. None of the reported cases has led to serious injury of the user. However, the possibility of serious injury cannot be completely ruled out, especially in the case of patients with a tracheostomy.

According to the manufacturer, affected users can continue their inhalation treatment with the PARI SOLE N /PARI SOLE N Tracheo device. However, in order to prevent liquid getting in, the nebuliser lower section must not be exposed to liquid for longer than 60 minutes (for purposes of cleaning, disinfection or sterilisation). Avoid for example leaving the nebuliser in a cleaning solution for hours at a time, as this is not what the product is intended for.

Particular caution is advisable in the case of patients with a tracheostomy as their mouth and throat cannot provide their natural protection. In addition to the Instructions for Use, patients with a tracheostomy are advised to ensure that the temperature of the aerosol does not exceed 43 °C before each use. This can be best done as follows:

• After the inhalation solution has been added and the nebuliser has been attached, switch the device on as described in the Instructions for Use.
• Wait until the heating phase has been completed and the device is ready for operation (LED display is green).
• Before placing the nebuliser on the tracheostomy, press the interrupter button on the nebuliser and use a thermometer to check the temperature of the aerosol coming out at the tracheostomy mask.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON333619

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 12 November 2013