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 Date 01/18/2021 |
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.The device will undergo deep disinfection in order to solve the reported contamination.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 that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.The laboratory report confirming the reported contamination has been provided to livanova.There is no known patient involvement.
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Manufacturer Narrative
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H10: 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 theater during use with the fan directed away from the patient and at an estimated distance of two (2) meters from the surgery field.
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Event Description
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See initial report.
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Search Alerts/Recalls
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