Model Number 16-02-82 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2023 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t displayed error on patient side during a procedure.There is no report of any patient injury.
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Manufacturer Narrative
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Follow up with the customer confirmed the error could not be remembered.A livanova field service engineer was dispatched to the customer site and the claimed error on patient tank display was not reproducible.The unit was found empty and refilled and then it was observed a leak from patient circuit tubing.Finally visual inspection and functional safety checks were successfully completed per guidelines and unit 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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Manufacturer Narrative
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H10: complaints database analysis revealed that no similar event on this device occurred since its installation in (b)(6) 2017.Based on technical intervention and on the fact that the issue occurred during maintenance activity, it is reasonable to assume that the root cause of the reported event was due to an unintended use error during cleaning procedure, which resulted in the claimed error.
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Event Description
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See initial report.
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Search Alerts/Recalls
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