Model Number 48-50-00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Air Embolism (1697)
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Event Date 10/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was not provided.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 the machine and could not identify any issues with the device.The pumps were checked and found to be working within specifications.The bubble sensor was checked and found to have slight dimpling in the bladder.However, it was found to be working properly and within specifications.In the extreme condition, a deflated bladder may result in oversensing of the bubble detector which will detect air bubbles even if no air bubble is present in the line.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Livanova attempted to retrieve additional information about patient conditions and additional details about issues experienced during the procedure but no answer was provided.The biomedical engineer of the hospital communicated to livanova representative that likely the customer will not give any information about the event or the outcome.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 received report of an adverse outcome.Issue with air, air lock and low flow during a procedure were reported by the biomedical engineer of the hospital and a s5 system was used.The outcome of patient has not been communicated to the biomedical engineer of the hospital or to any livanova representative.No additional information were provided.A patient impact cannot be excluded.
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Manufacturer Narrative
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H.10: a review all of the dhr could not identify any deviations or non-conformities relevant to the issue.Based on the intensive tests performed on site by the livanova field service technician, hardware/software malfunctions with the s5 console can be ruled out as cause of the reported event and it is unlikely that the reported event was device related.
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Event Description
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See initial report.
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Search Alerts/Recalls
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