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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Medtronic: “Infuse lawsuits coming to a close”
Medical device company, Medtronic, has recently suffered a lengthy legal headache when the company faced allegations of defrauding shareholders by reportedly covering up negative side-effects of its Infuse bone growth product for 10 years.
Infuse is a genetically engineered protein that causes bones to fuse for use during lower spinal surgery; intended as an alternative to bone grafts. Thousands of patients complained that the product was used inappropriately and that it had caused permanent and devastating injuries.
These were allegedly covered up.
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Exploding Takata airbags: many millions involved in recalls
There have been multiple calls to get Takata inflators out of vehicles and off the roads for several years, and after a crash where a Takata airbag reportedly nearly caused a woman’s death, these calls are getting louder.
Karina Dorado’s trachea was reportedly punctured by shrapnel from a Takata inflator. The crash, which happened on 3rd March 2017 in Las Vegas, should’ve been just a minor collision, but things escalated quickly. Ms Dorado was rushed into a trauma centre where surgeons removed pieces of the airbag device that had damaged her vocal cords.
She is still being treated for neck injuries.
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Cancer associated with breast implants used in reconstructive surgery
Insurance agent Raylene Hollrah was diagnosed with breast cancer in 2007. The successful businesswoman, who owns her own insurance company, made a life changing decision; she underwent chemotherapy and had her breasts removed and reconstructed.
Hollrah made the brave decision to go through painful and gruelling surgery and treatment in the hopes she would free herself from breast cancer. Unfortunately, six years later, Hollrah was diagnosed with cancer again.
Shockingly, it wasn’t a return of the breast cancer; it was a “rare malignancy of the immune system” that was reportedly caused as a result of the breast implants used in her reconstructive surgery…
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Call for U.K. public inquiry into vaginal mesh implants
Senior doctors in the U.K. have called for a public inquiry into the use of vaginal mesh surgery. This comes after growing concerns that patients who have undertaken the surgery have been scarred for life.
Vaginal mesh implants are a net-like implant usually made out of polypropylene plastic and are used to treat pelvic organ prolapse, and stress urinary incontinence in women who may have these conditions as a result of hysterectomy, menopause or childbirth.
The problems that can occur if the devices fail can be catastrophic.
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Maserati, BMW and Mercedes-Benz vehicles recalled after fire risk
Fire risks in vehicles appear to be a growing phenomenon. Several manufacturers have voluntarily recalled vehicles for fire risks recently, and it’s not a thing to be dismissed lightly.
Imagine a vehicle cruising at 70mph on the motorway when it suddenly sets on fire. It’s a clear recipe for disaster and could endanger many lives, including your own.
In recent news, Maserati, Mercedes-Benz and BMW have all recalled vehicles for reported risks of fire…
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Aerotoxic syndrome: the new phenomenon we may have been dismissing for years?
Whilst not officially recognised, more and more cases of “Aerotoxic syndrome” are being reported, and cases continue to raise concerns over air quality inside flight cabins.
Over the past decade, a number of shocking incidents have occurred where pilots have almost collapsed from fumes, and planes have been turned around with crew members falling sick. In the past few years, a handful of flights had to perform emergency landings.
Pilots, crew members and passengers may all be at risk when exposed to engine fumes inside a tightly compressed cabin space, thousands of feet in the air. The dangers are real…
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Class 2 recall for Diclo-SR 75 pain-relief tablets
A Watford-based pharmaceutical company has issued a voluntary recall for batches of Diclo-SR 75 pain relief tablets – AKA diclofenac sodium.
The tablets are commonly used for pain relief and swelling for arthritis, musculoskeletal disorders, gout and pain caused by injury or minor surgery. The tablets are classified in a group of medicines called non-steroidal anti-inflammatory drugs.
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Regulators issue urgent recall over “toxic” spinal fusion stimulators
Regulators have issued a top-level recall over Zimmer Biomet SpF spinal fusion stimulators amidst concerns that the medical devices contain chemicals that can seriously harm patients, and even be fatal.
This is a serious recall given there is a reasonable probability that using a certain defective product can serious injure or kill the patient. It’s reported that 33 affected units were manufactured and distributed.
The affected stimulators are the SpF-XL IIB (22 units) and the SpF- Plus (11 units)
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Alvogen recalls 24 lots of hypertension drug off the market due to chemical contamination
A medical drug manufacturer has initiated a voluntary recall on 3rd July 2017 after concerns their Nifedipine tablets have become contaminated with other medication ingredients.
The company, based in Iceland, makes the hypertension drug under the brand name Adalat, which is supplied to Bayer HeathCare. It’s used for channel blocking and as treatment for hypertension (high blood pressure).
The recall was initiated after a potential cross-contamination between the Nifedipine and another drug in the same facility.
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MHRA issues a medical device failure alert as all HeartStart MRx defibrillators might not deliver lifesaving shocks
According to our Medicines and Healthcare products Regulatory Agency (MHRA), certain defibrillators may fail to deliver controlled shocks, cardioversion, pacing or monitoring.
The HeartStart MRx defibrillators are manufactured by Philips Healthcare and it’s believed the fault lies with the batteries. The lifesaving medical devices could fail to turn on or reboot themselves repetitively, therefore hindering administrators from being able to deliver shocks. The device could also “fail to deliver a shock or undertake pacing” after it has been unplugged from AC mains.
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