LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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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).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 received report vk_20200525_18 from swissmedic that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera, mycobacterium chelonae / abscessus complex and paragordonae.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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H.10 through follow up communication under previous complaints from the same hospital, livanova deutschland 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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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