Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova will attempt to retrieve additional information.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 (b)(4) received a report from danish agency that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.There is no known patient involvement.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the device is cleaned regularly per the instruction for use and that it was placed both outside and inside the operation theatre.If placed inside, the fan is directed in parallel to the surgery field at three (3) meters distance.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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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