Case study: Blood gas analyser

Background information

A neonatal ward made a report regarding a number of false results obtained from a blood gas analyser. The cases involved blood samples taken from babies during delivery. Concerns were raised because important treatment decisions could have been made based on these false test results. On this occasion, treatment decisions were not affected as a trained member of staff had spotted the incorrect results.  

Investigation

The Medicines and Healthcare products Regulatory Agency (MHRA) and the manufacturer revealed that the blood gas analyser was relatively new and not all staff using it had been trained correctly in its use. In addition, some staff did not know how to collect a good quality sample. 

Response

The MHRA asked the manufacturer to visit the hospital and provide further training on how to collect higher quality blood samples for testing. The MHRA also facilitated conversations between staff involved in this. As a result, the ward’s Standard Operating Procedure (SOP) was updated according to best practice and MHRA has not received any further reports of false readings at the time of this being published. 

Result

MHRA advises that all users are trained in the use of a new device and when a new device is put into service ensure that SOPs are updated accordingly. 

This case demonstrates why it is important to report any adverse events concerning devices to MHRA. This could include any safety issues such as: device design, unsuitable storage conditions, poor user instructions, inappropriate modifications, inadequate maintenance or - as was the case in this incident – lack of training. 

Additional information

A blood gas analyser is a machine that measures oxygen, carbon dioxide, pH, electrolyte, and metabolite levels in blood samples.  

Neo-natal is relating to or the affecting of a newborn and especially the human infant during the first month after birth.

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