Patient identifier, age, weight: patient information was requested but not provided.Description of problem or event: the referenced console is reported under mfr.Report #2916596-2019-02669.The referenced blood pump is reported under mfr.Report #2916596-2019-02841.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Section a1, a2, a4, h4: additional information.Section d3, g2: correction.Manufacturer's investigation conclusion: the centrimag motor used at the time of the reported event was not returned for analysis.Multiple attempts to obtain the product were unsuccessful.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (doc.(b)(4)) has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.
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