LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-85 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Event Description
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Livanova received report that a heater cooler system 3t gave ee error during maintenance.Reportedly, the device worked afterwards but the customer requested the machine to be checked.No additional information is available up to date and the event is conservatively considered reportable.There was no patient involvement.
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in rock hill, south carolina.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The device was found to be working within specifications and no deviation could be found.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Through follow-up communication livanova learned that the customer noted the error code while filling the device tanks with water.Based on service activity findings and collected information, the reportability decision has been changed to not reportable event.Indeed, the error is most likely one of the three (3) error codes which are expected to be displayed on the device during device filling phase and to disappear once filling is completed.Therefore, the issue is not likely to result in serious injury and it is always detectable prior device use.
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Event Description
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See initial report.
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