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 06/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.(b)(6).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).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.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.Device not returned.
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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.Hospital performed lab test, which confirms the contamination with mycobacterium chimaera.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 for complaint # (b)(4).Livanova deutschland has been informed that the customer used reusable heating blankets.It is likely that those pads are source of contamination, therefore the customer swap them with disposable ones.The information received under complaint # (b)(4) is likely valid also for this case.
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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 with the customer livanova deutschland learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operation theatre with the fan positioned opposite to the patient, at an estimated distance between the surgery field and the device of two (2) meters.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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See initial report.
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Search Alerts/Recalls
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