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 Date 12/30/2019 |
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: 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.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)(6) received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.The lab report confirming the reported contamination has been provided to livanova.The device will be scrapped.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 was cleaned as per the instruction for use since when the device was upgraded.It was placed inside the operation theatre during use with the fan directed opposite to the surgery field.The laboratory report confirming the reported contamination by real-time pcr has been provided to livanova.The device was manufactured in 2007 thus no deep disinfection will be conducted to solve the issue because the device will be scrapped.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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