Model Number 48-40-00 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information: there was no patient involvement.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and tested the device intensively.The service representative could not reproduce the issue.He found that the system was working within specification.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report that the level sensor alarm did not triggered the reaction of the electrical clamp during procedure.The level dropped down and the perfusionist clamped the line, thus reaching the proper level again.The procedure could be completed without further issue.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the affected device has been requested back to the manufacturer site for a detailed investigation.During tests an error code was detected.This error does not allow the clamp to properly close at the level alarm.Blood spots and dried saline solution have been detected into the clamp.Fluid ingress issue has been identified to be the root cause of the event.
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Search Alerts/Recalls
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