THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 201-30300 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The associated centrimag 2nd generation primary console, sn: (b)(4) is reported under mfr # 2916596-2020-00891, and the associated centrimag motor, ous, sn: (b)(4) is reported under mfr # 2916596-2020-00892.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that there was an s3 alert on the console while the system was in use on a patient in an ambulance en-route to the hospital.There was also no flow probe reading.The back-up console was attached and initially got a reading.However, then the same s3 alert appeared and the flow probe did not have a reading.The device was detached from the ambulance power supply and turned off and on.Following that the flow probe worked fine for the duration of the journey.There were no adverse patient effects.No further information was provided.
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Manufacturer Narrative
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Section d10: additional information.Sections d4, h4: the device serial number was requested but was not provided, and therefore no expiration or manufacture dates are available.Manufacturer's investigation conclusions: the reported event of an s3 alarm occurring on the backup centrimag console was not confirmed.The backup centrimag console (serial number unknown) was not returned for analysis, and no log files regarding the console were provided.Per additional information, details regarding the console were unable to be obtained.The root cause of the reported event was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.
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