Model Number 75210 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/19/2015 |
Event Type
Other
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Manufacturer Narrative
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Sorin group (b)(4) is the mfr of the electa essential cell separator.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the electa autotransfusion device displayed an error message during setup.Rebooting the system did not correct the error.The system was not used.There was no pt injury.The investigation is ongoing.A f/u report will be sent when the investigation is complete.
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Event Description
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Sorin group received a report that the electa autotransfusion device displayed an error message during setup.Rebooting the system did not correct the error.The system was not used.There was no report of pt injury.
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Manufacturer Narrative
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(b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative tested the unit but was unable to reproduce the reported malfunction.Preventive maintenance was performed without malfunction and the device was returned to service.As the issue could not be reproduced, a root cause was not determined and corrective actions were not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.
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Search Alerts/Recalls
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