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 01/10/2024 |
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 an error message associated to patient circuit pump that uses too much power during disinfection.There was no patient involvement.
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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 vero beach, florida.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 communication with livanova field service representative, it was learned that service intervention has been canceled since the issue only presented during the disinfection cycles.A device service history review has been performed and identified that the unit was manufactured in 2023 and no other similar events have been received.Based on all the collected information, it cannot be excluded that an accidental user error during the disinfection cycles may have contributed to the reported 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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