Maquet Cardiovascular have issued a Safety Notice concerning the temperature reading on a certain number of PLEGIOX Cardioplegia heat exchangers. The problem is limited to selected lot numbers and only affects a small number of hospitals in the UK. The cause of the problem is a change to a moulded component, which restricts the depth the external temperature probe can be inserted into the device. There could be up to a three degree Celsius difference in read and actual temperature however the performance of the heat exchanger is unaffected.
The Safety Committee would like to make the UK community aware of this situation, which is being dealt with by the Maquet Technical Services team. Further information and affected lot numbers can be found in the following documents Plegiox Field Safety Notice.pdf and Plegiox Lot Numbers.pdf, which can be accessed below:
