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.
Continue Reading…
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.
Continue Reading…
NovoPen insulin pens recalled over risk of hyperglycaemia
Certain batches of insulin pens manufactured by Novo Nordisk have been recalled as the cartridge holders may not be strong enough to withstand some household cleaners.
The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a medical device alert to notify hospitals and users to return affected batches to Novo Nordisk for replacement.
NovoPen Echo and NovoPen 5 are both affected by the recall. A total of 87 batches in the U.K. have been recalled by way of a field safety notice, citing broken or cracked cartridges as the problem.
Continue Reading…
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.
Continue Reading…
DePuy Synthes Impactor for PFNA blade recalled over risk of infection
Manufactured by Synthes, the DePuy impactors used for Proximal Femoral Nail Antirotation (PFNA) have been recalled over potentially dangerous risks of infection. PFNA’s are metal devices inserted into the femur bone to strengthen it.
The U.K.’s Medicines and Healthcare Products Regulation Agency (MHRA) has noted a defect with the medical device as a crack in the weld of the handle. The recalled blade is used to insert and position the PFNA in the centre of the bone, and the operating physician uses the handle to grip and position the attached PFNA. It is the handle for the PFNA Blade impactor that can crack, and continued use may mean bodily fluids like blood or bony debris can get inside the device, risking cross-contamination when it’s used for other patients.
Continue Reading…
Are we facing an “opioid epidemic”?
We’ve already acknowledged a reported over-reliance on prescription medication here in the U.K., with fears of an “opioid epidemic” in America creeping across the pond to our shores as well. Unless, it’s already here…
In what’s being described as an “epidemic” and a “crisis” in the U.S., opioids are apparently being used way too much, leading to serious and needless addictions whilst reportedly lining the pockets of the super-rich pharmaceutical corporations.
We look at this growing problem and comment on why we ought to be concerned.
Continue Reading…
Pregnant mothers given antidepressants linked to children born with psychiatric illness
A new study reportedly shows that children whose mothers took antidepressants whilst pregnant with them may have an inflated risk of psychiatric illness.
The study, published by the British Medical Journal (BMJ), found that 32,400 of the 905,000 children participants in a 16-year-long study were diagnosed with a psychiatric disorder. Although statistically only 3% of the total study group, 32,400 is still a significant number that may have in theory been reduced if expectant mothers received more warning about the potential risks to their unborn child.
Continue Reading…
Johnson & Johnson ordered to pay out over £300 million for “carcinogenic” talcum powder
Global healthcare company Johnson & Johnson have been ordered to pay around £319 million in damages to a woman after she developed ovarian cancer allegedly from using their talcum baby powder.
The jury came to the conclusion that the company failed to warn consumers of the alleged risks associated with ‘perennial talc exposure’ – specifically the apparent heightened risk of developing ovarian cancer.
The lawsuit cited the International Agency for Research on Cancer classification of talcum powder as a possible carcinogenic substance in 2006.
Continue Reading…
Amazon’s solar eclipse viewing glasses recalled as potentially counterfeit
“When you look directly at the sun, the intensity of the light and the focus of the light is so great on the retina that it can cook it,” warns President of the American Optometric Association.
Growing up, we’ve always been told not to look directly at the sun. Parents and teachers warn that its burning light could literally blind you. Looking at the sun can cause burns, and blister and crack the cells in your cornea. The consequences of looking directly at a solar eclipse can be far worse, and experts recommend that you must always use appropriate eyewear with special filters to protect your eyes.
But what if the eye protection doesn’t work?
Continue Reading…
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
Regulators expand investigations into Ford Explorer SUVs over concerns of carbon monoxide leaking
Regulators are investigating Ford Explorer SUVs that may be leaking harmful carbon monoxide from their exhaust systems.
The popular and reputable models are commonly used by U.S police forces, and earlier this year between March and July, six police officers were reportedly taken to hospital to be treated for carbon monoxide poisoning.
Five officers required treatment but were not kept overnight, and the first police officer who was admitted for carbon monoxide poisoning in March was reportedly placed on medical leave for around a month.
Continue Reading…
Defective Takata airbag may reportedly be involved in traffic fatality
We’ve been covering the Takata airbag scandal for some time now, and news has emerged of another potential fatality that may be directly linked to the defective airbags.
A woman reportedly died from injuries sustained in a car collision in July this year, which involved a Honda Accord 2002 said to be fitted with the recalled Takata airbags. In the incident, another vehicle failed to yield right of way and collided with the victim, and although authorities have yet to confirm whether or not the cause of death is linked to an exploding Takata air bag inflater, it has not been ruled out.
Continue Reading…