Model Number 16-02-80 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/20/2020 |
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 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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Livanova received a report about an heater cooler found acid-fast bacillus contaminated.There is no evidence of any patient involvement.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the device was cleaned and maintained as per the ifu.The device was placed inside the operating theatre during use with the fan directed away from the patient at an estimated distance from the surgery field of 2-4 meters.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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