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After US pharma major Abbott reported that it’s artificial pumping device used in patients during heart surgery is facing technical issues, US Food and Drug Administration (US-FDA) has labelled it a Class I recall, which is the most serious type of recall.
The regulator has warned that use of these devices may cause serious injuries or death.
Even as Abbott supplies this product to 27 countries including India, the company has clarified that the product has not been distributed in the Indian market, though it has been supplied to the country.
In August, Abbott reported voluntarily that 44 injuries and 1 death due to the faulty ‘CentriMag System,’ that is intended to pump blood through a patient for up to six hours during open heart procedures. The system also provides temporary blood circulatory support for up to 30 days for patients in cardiogenic shock when the right side of the heart loses pumping power and blood backs up in the body's veins (acute right ventricular failure).
In an alert, US-FDA also stated, “The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.”
The company said that the affected lot numbers are L05333-0001 to L06608-0024. Upto 664 units (381 in the US and 283 outside US in 27 countries including India) were found affected. A calibration system error resulting from electromagnetic interference may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms. If the pump slows or stops, the patient is at risk of service adverse health consequences such as stroke, severe organ damage or death, US-FDA stated.
Even as there would have been the products in question in Abbott’s inventory in India, they had yet not entered the market, a company spokesperson confirmed. Even as patients from India have not been impacted according to the company, the Drug Controller General of India was apprised of the situation by Abbott.
The spokesperson told Businessline , “Abbott informed our hospital partners in concerned countries in August about the potential for electromagnetic interference to disrupt the operation of the CentriMag system.”
The spokesperson further said, “All impacted hospitals were made aware of the issue and Abbott replaced improperly configured systems to ensure the safety of our patients. There were no systems from the concerned lot in the Indian market. Hence, there has been no impact on patients in India. As per MvPI (Materiovigilance Programme of India) requirements, we informed them of this notification.”
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