CentriMag (blood circulation support system)

2019: A withdrawal of the rejected systems

At the beginning of November, 2019 it became known that Abbott withdraws the rejected support systems of blood circulation of CentriMag because of which people perish. Regulatory bodies of the USA released about it warning of the I class, i.e. warning of defects, life-threatening the person.

The Abbott company began to withdraw the rejected systems in August, 2019 when messages about one lethal case and 44 injuries connected with the rejected equipment arrived. The CentriMag system on the basis of Levitronix and Thoratec technologies should replace temporarily heart at open transactions and also provide external blood circulation for a period of up to 30 days at cardiogenic shock. It turned out that owing to an error of calibration CentriMag created the electromagnetic interferences breaking operation of the system console. These errors led to the fact that the pump slowed down work or completely stopped.

The rejected support systems of blood circulation of CentriMag because of which people perish

In certain cases suddenly the console screen died away, and a system gave chaotic alarms. The sudden stop of a pump during transaction is capable to lead to development of serious zhizneugrozhayushchy injuries, as was observed in some cases, including with a lethal outcome. Besides, the created electromagnetic interferences influenced the important equipment which was near the rejected system.

In August Abbott informed partners on the revealed defects of the CentriMag system. All hospitals with the rejected equipment were notified on this problem, and Abbott began to replace incorrectly customized systems to ensure safety of patients. In total 381 devices were recalled. In the letter of Abbott of August 22, 2019 it is said that in the absence of electromagnetic interferences of hospital can continue to use the CentriMag systems before repeated calibration.^[1]

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