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 07/20/2019 |
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, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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 (b)(4) has started an investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The investigation is ongoing.Corrective actions are in progress for this 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 (b)(4) received a report, that a heater-cooler system 3t was found to be contaminated with mycobacterium spp (species pluralis).Hospital performed lab test, which confirms the contamination with mycobacterium spp (species pluralis).The report has been provided to livanova (b)(4).There is no known patient involvement.
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Manufacturer Narrative
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Through follow up communication, livanova deutschland learned that the device cleaned regularly as per the ifu and was placed inside of the operation theater during use, with an orientation away from the operating table and an estimate distance of 2 meters.Through further follow up communication, livanova deutschland learned that the unit has been tested again since this was reported and the outcome was a negative test result.
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Event Description
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See initial report.
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