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 09/29/2020 |
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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Manufacturer Narrative
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Through follow-up communication livanova learned that the device was cleaned regularly as per the instruction for use and that it was placed inside of the operating theatre during use with the fan directed opposite to the patient at an estimated distance of 3-4 meters.In addition, livanova learned that the water quality monitoring was not applied.This deviation from the ifu may have led/contributed to the reported contamination.
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Event Description
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See initial report.
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Search Alerts/Recalls
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