Model Number 48-30-00 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that during procedure a s5 roller pump did not stop after the liquid passed through the bubble sensor; the user did not see any visual or audible alarm.The circuit used by the customer includes an air purge control (apc) filter utilized with a servo drive on a s5 roller pump and a 3/8" bubble sensor.The s5 system was linked to a centrifugal pump system (scp).There was no patient injury.
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Manufacturer Narrative
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A.1.-a.5.Patient information was not provided h10: livanova deutschland manufactures the s5 system.The incident occurred in france.A livanova "initiated" an investigation.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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Through follow-up livanova discover that the problem came back only once and there is doubt about bubble sensor installation.The field service eng.Set-up an apc loan module and requested additional investigation from apc expert.If additional relevant information will be provided a follow-up report will be submitted.
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Manufacturer Narrative
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A complaints database review was performed and no other issue has been reported for the claimed unit since its installation in 2017.Moreover, no other similar occurrence has been submitted by the customer in the past and following apc module replacement.Based on available information, it cannot be ruled out that the reported issue can be traced back to a defective apc module.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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Search Alerts/Recalls
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