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 03/31/2020 |
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 report vk_20200526_14 from swissmedic related to 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 (samples from (b)(6), 2020).There is no known patient involvement.
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Manufacturer Narrative
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A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Through follow up communication under previous complaint from the same hospital and for the same unit, (b)(4) learned that the device was cleaned regularly per the ifu, placed inside of the operation theater during use, with the fan facing away from the patient in direction of an exhaust fan in the wall.The device was kept in a housing with negative pressure in relation to the pressure in the or.The estimated distance between the surgery field and the device was 3 meters.
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Event Description
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See initial report.
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Search Alerts/Recalls
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