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 03/27/2020 |
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 (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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Event Description
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See initial report.
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Manufacturer Narrative
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H10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.Through follow-up communication under another complaint from the same hospital livanova learned that the customer regularly cleaned and maintained the device according to the instructions for use.The device was place inside the operating theatre during use with the fan opposite to the patient and at an estimated distance of three (3) meters from the surgery field.The device will undergo deep disinfection in order to solve the reported contamination.
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Search Alerts/Recalls
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