CareFusion syringe pumps are incompatible with any syringe type

Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA/2016/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine.

Medical device alert 1

On 22^nd December 2016, MHRA, whom are responsible for ensuring that medicines and medical devices are safe and work accordingly, issued a medical device alert.

In summary, the Alaris syringe pumps are manufactured by CareFusion, they essentially provide fluids to patients continuously. They warned that using non-recommended syringes in Alaris syringe pumps that have a broken spring in the plunger assembly, may cause the build-up of medication of up to 0.5ml. This could create a significant problem for child patients.

The problem occurred from using a combination of non-recommended syringes with a pump that has a broken spring in the syringe driver plunger housing. At the time, CareFusion didn’t identify any increased risk of the problem when the recommended syringes were used.

The MHRA recommended the following actions:

• If the pump keeps showing ‘check syringe’ alarms, contact CareFusion to discuss how to check the springs stored in the plunger holder.
• Only use the recommended syringes listed in the instructions for use for these pumps.
• Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s recommendations.

Medical device alert 2

Following on from this, the MHRA issued an updated medical device alert on the 20^th February 2017. CareFusion notes that the potential for build-up of medication applies when any syringe type is used in a pump that contains a broken spring in the plunger assembly. Prior to this alert, it was thought that the bolus build up applied to the use of non-recommended syringes.

The MHRA has recommended the following actions:

• Contact CareFusion to discuss how to check the springs housed in the plunger holder.
• If a broken spring is identified, contact CareFusion to arrange for the faulty springs to be replaced.
• Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s recommendations
• They also noted that this alert replaces the medical device alert which was published in December 2016.

There are deadlines imposed on the medical device manufacturer. Actions must be completed by 26^th April 2017.

Importance of the MHRA

It’s crucial that the MHRA regulates medicines and medical devices as without them, there could be disastrous consequences with unregulated medicines and medical devices.

The main aim of the Healthcare watchdog is to safeguard the public’s health. They do this by ensuring that medicines and medical devices work properly and are acceptably safe. They also highlight and respond to concerns of ‘unsafe’ medicines and medical devices. Though they can’t guarantee that medicines and medical devices will be 100% risk free, the MHRA tries to ensure the risks are minimised as much as possible.

When weighing up medicines and medical devices, the MHRA has to consider:

• Do the advantages outweigh the disadvantages of taking the medicine?
• Does the medicine do the most good for the least harm for most people who will be taking it?
• Are the side effects acceptable?

Alhough they are a governmental body, the MHRA’s decisions are impartial and based on extensive evidence of quality, safety and efficiency.

The MHRA’s work doesn’t go unnoticed as they receive approximately 8,000 device reports annually. This is a substantial number which could consequently save lives and prevent injuries.