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 03/20/2019 |
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).Recall numbers: 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 could not identify any deviations or nonconformities relevant to the 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 vigilance report of swiss medic (competent authority of (b)(6)), that a heater-cooler system 3t was found to be contaminated with mycobacterium chelonae.The lab report confirming contamination with mycobacterium chelonae has been provided.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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Through follow up communication, 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 o.R.The estimated distance between the surgery field and the device is three meters.Furthermore, livanova deutschland learned that the device is in use at the moment.Customer confirms that the cleaning and disinfection process is recorded in a log.The device will be returned to livanova deutschland for deep disinfection procedure.
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