Devices: Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device. Manufactured by Smiths Medical from October 2007 to February 2008 inclusive. Problem:A fault in the manufacture of the trigger flush device can lead to over-infusion of fluid and falsely elevated blood pressure measurements. Following the publication of MDA/2008/024, the manufacturer has amended its customer field safety notice to clarify the number of drops deemed acceptable. The manufacturer has informed the MHRA that there is insufficient stock to conduct a total withdrawal of the affected devices. Action by: Theatre, intensive care, high dependency, cardiac catheterisation laboratory and accident and emergency clinical staff. Action:
- Be aware that this alert supersedes the advice given in MDA/2008/024 (issued on 7 April 2008).
- Identify product codes of affected devices (see Device section on next page).
- Check for excessive flow rate (see Action section on next page).
- Malfunctioning devices should be quarantined and reported to the MHRA.