The FDA has issued an alert about a potentially high-risk issue involving Abiomed’s Automated Impella Controller, which is used with the company’s blood pump systems.
Abiomed, now part of Johnson & Johnson Medtech, notified customers June 23 with updated instructions for use and urgent recommendations, including having a backup AIC console on hand in the event of a device failure, according to a July 1 news release from the agency.
The FDA noted that the AIC may fail to detect a pump during console-to-console transfer or initial case startup without displaying a visual alarm. This could lead to inadequate hemodynamic support, posing critical risk for patients in cardiogenic shock.
The devicemaker recommends immediately switching back to a functioning console if the screen remains stuck after 20 seconds during a transfer or case start.
The issue has been linked to three patient deaths.
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