Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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There was no 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).No information about cleaning and disinfection procedure are stated within the article.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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Through literature review livanova became aware of 14 heater-cooler 3t devices contaminated with mycobacterium chimaera at three (3) different and not specified hospitals.The serial number of devices involved as well as hospital names remain unknown.There is no known patient involvement.
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Manufacturer Narrative
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H.10: the serial number of devices involved as well as hospital names remain unknown.No information about cleaning and disinfection procedure are stated within the article.No further investigation is possible thus the root cause of the reported contamination cannot be determined.
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Event Description
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See initial report.
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Search Alerts/Recalls
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