Model Number 16-02-85 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in brooklin, new york.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The patient pump and the distribution board were replaced and the problem could be solved.Also circulator motor was replaced since it was noisy.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 a patient pump during procedure.There was no patient injury.
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Manufacturer Narrative
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H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2021.It cannot be ruled out that the motors noise was correlated to a fault of mechanical origin which led to excessive consumption of power such as creating damage to the distribution board to which the motors are connected.
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Event Description
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See initial report.
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Search Alerts/Recalls
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