Model Number 16-02-85 |
Device Problems
Pumping Problem (3016); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland 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 deutschland received a report that a heater-cooler system 3t displayed an error message associated to patient circuit 2 pump that uses too much power.The issue occurred during disinfection procedure.There was no patient involvement.
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Manufacturer Narrative
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In consultation with the customer, it was decided that the patient circuit 2 pump that uses too much power error (ee21) was occurring only during the disinfection cycles and not during use in a case.Notified the chief perfusionist and asked her to monitor the units in case it happens again.Agreed with the customer to cancel the service activity.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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See initial report.
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Search Alerts/Recalls
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