Model Number 16-02-85 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).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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Event Description
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Livanova (b)(4) received a report that a heater-cooler system 3t was not cooling on patient side during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the customer canceled the service request since the reported event was related to a perfusionist issue.Reportability decision changes to not reportable event based on the fact that the device did not malfunction and the hospital reported that it was a user issue.
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Event Description
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See initial report.
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Search Alerts/Recalls
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