Model Number 16-02-85 |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Livanova deutschland has received a report that the calendar summary table of the quick reference guide included in some 3t heater coolers are not aligned with 3t heater cooler ifu.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 united states.Livanova has 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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See initial report.
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Manufacturer Narrative
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H10: livanova has identified that quick reference guide (qrg) version 22 contains inconsistent information regarding the disinfection calendar table in page 3 of the current usa qrg.The information on the qrg is not aligned with current usa version oi of 3t heater cooler.Medical device correction z-0073-2024 (livanova ref.Fa-cp-mun-2023-001) was deployed to inform affected customers, remove already distributed incorrect copies and provide the corrected revision of the qrg.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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