Tag: mhra
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.
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Unomedical concentration oxygen mask recalled over dangerous defect
Unomedical concentration oxygen masks provide vital oxygen for patients. However, the Medicines and Healthcare products Regulatory Agency (MHRA) has found that a manufacturing fault could be disrupting supply, which could lead to oxygen deprivation for patients using the faulty oxygen masks.
This has led to an increased risk of Hypoxia (deficiency in the amount of oxygen reaching the tissues).
Manufacturer ConvaTec issued a voluntarily recall on 10th May 2017 over concerns of health risks to patients. ConvaTec also distributes the affected oxygen masks to multiple countries in several European countries as well as Rwanda and Saudi Arabia, making this a far-reaching issue.
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