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 10/31/2018 |
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).Recall number: 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)(4).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions are in progress for this issue.
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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 chimaera.The lab report has been provided to livanova (b)(4).Within the report it is stated, that the unit has been cleaned and disinfected according to ifu and is placed outside of the operation room.There is no known patient involvement.
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