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 date of event has not been provided.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Corrective actions are in progress for this issue.
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Event Description
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Livanova (b)(4) received a report 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: the laboratory report has been provided.Differently from what reported (m.Chimaera contamination), presence of pseudomonas species and mycobacterium avium complex (mac) is stated in the tests results.Within the report is also stated the presence of biofilm and probably m.Chimaera.Through follow-up communication livanova learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theatre during use with the fan directed opposite to the patient.The estimated distance between the surgery field and the device was 3 meters.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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Manufacturer Narrative
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H.10: the initial reporter information have been corrected in the dedicated section e.
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Event Description
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See initial report.
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Search Alerts/Recalls
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