Tag: mhra
Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation
Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths may have occurred as a result.
The heart controls the blood flow in our bodies and relies on aortic valves to ensure the blood is pushed in the right direction to reach our organs and limbs. However, over time, these valves can become weak or damaged and don’t close properly which can lead to blood leaking back into the heart, making it much harder for the heart to pump it outwards to the rest of our bodies, resulting in heart failure. Artificial mechanical valves can be fitted to replace the weakened or thickened valve.
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Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet/Getinge. The alert closely follows the one issued over the Datascope Corp’s similar devices that were found to have an electrical fault.
This new alert identifies a “false blood detection alarm and/or fluid ingress” that can also risk failure of therapy to patients. The medical device is used to help the patient’s blood flow, pumping at the same rate as a heartbeat, and is usually used for patients whose hearts may not be strong enough to function alone.
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Medical device alert for Datascope Corp intra-aortic balloon pumps
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp.
Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.”
The medical device cites at least one report of a death involving an allegedly failed CS300 intra-aortic balloon pump. It’s not known how many non-fatal injuries have been caused by the faulty pumps as well.
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MHRA issues medical alert over Comprehensive Nano Humeral Components
The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components over risks of needing revision surgery when used in reverse configuration.
The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices.
The comprehensive ‘nano humeral component’ is usually used in the anatomic or reverse configuration, but after an annual review was conducted, the study data indicated the device was not fit for use in the reverse configuration.
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Medical device alert issued over damaged VITEK 2 test cards exposing risk to antibiotic degradation
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert over VITEK ® 2 AST Test Cards after the discovery that when the cards are exposed to moisture, it can stop antibiotics from working.
Manufacturer BioMérieux published a Field Safety Notice to inform consumers of the issue at hand, and confirm the potential problems. The Notice explains that a defective test card may:
- Yield false resistance for antibiotics on the AST panel
- Cause a false negative ESBL test
- Result in a false positive urea reaction on ID cards
Depression and chronic pain relief drug, Duloxetine, recalled after failing tests
The drug Duloxetine, more commonly known as its brand name Cymbalta, is generally used to treat depression, anxiety, and chronic pain. It’s an active ‘serotonin-norepinephrine reuptake inhibitor’, providing pain relief for patients with diabetes or sufferers from chronic or widespread pain.
The drug is commonly prescribed to people with arthritis and fibromyalgia. However, select batches of the Torrent Dutor Gastro-resistant Capsules have been recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) because “out of specification results for dissolution were obtained during routine stability testing”.
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The reported danger of Intersurgical’s BVM resuscitation device
A reported manufacturing fault of a medical device has caused a great deal of concern within the healthcare industry. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a field safety notice to notify healthcare providers and users alike.
Due to a reported manufacturing fault, the Bag-Valve-Mask (BVM) manual resuscitation system could cause injury or even death as the valve may become stuck during storage, possibly resulting in the intended airflow not being delivered. Consequently, there may be a delay in the treatment.
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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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