Medical device alert issued for Prismaflex Haemofiltration machines

A medical device alert has been issued warning hospitals and healthcare institutions that Prismaflex Haemofiltration machines are susceptible to software failure.

Machines manufactured by Baxter, and installed with the 6.10 version of software, may not compute information about syringe size and the brand of syringe used. As a result, the machine may revert back to default settings, which means it will work at the lowest possible plunger speed which may therefore lead to under-dosage.

When under-dosing occurs, a lack of anti-coagulants may be added to the blood. Without carefully measured anti-coagulants, the patient’s blood may then be at a high risk of clotting, which can of course lead to potentially serious consequences.

The issue

Haemofiltration machines are typically used for patients who have kidney failure and can’t filter their own blood effectively. As well as acute kidney injury, the machine is also helpful in providing relief for patients with multiple organ dysfunction syndrome and even blood poisoning. The patient is essentially ‘hooked up’ to the machine and their blood is extracted and filtered for any waste before being deposited back in the body.

Baxter have instructed all hospitals, healthcare institutions and providers who keep and use the machines to update them. Even after upgrading, physicians are instructed to:

If treatment has already begun when someone notices the syringe brand and size are mismatched (where the machine may have defaulted), cease use of the machine and contact Baxter’s Helpline.

Regulatory investigations

The Medicines and Healthcare products Regulatory Agency (MHRA) has identified the following who need to be informed of the alert:

Given the vulnerable nature of some of the patients who use Haemofiltration machines, there’s a risk of serious harm. Any problems with treatment could lead to varying health problems.

The important responsibilities of medical device manufacturers

Medical device manufacturers have a very serious responsibility for the products they produce. As users of these devices will often be patients who may already be vulnerable and more susceptible to consequential harm, even small problems can have very damaging effects on people.

If you’ve suffered injury because of a medical device not working properly, you could claim compensation. Medical devices should always be thoroughly tested before distribution, and systematically re-tested thereafter to ensure they remain safe for use.

Medical device liability is a particular specialism of the Group Action Lawyers, so we can help you.