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 02/13/2020 |
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.Livanova initiated an investigation.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 device was found to be contaminated with mycobacterium chimaera.The lab report confirming the reported contamination has been provided.There is no known patient involvement.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the device was regularly cleaned and maintained per the instruction for use.The device was place inside the opearting theatre during use with the fan opposite to the patient and at an estimated distance of three (3) meters from the surgery field.A site inspection was conducted and no deviation could be identified.The device will undergo deep disinfection in order to solve the reported contamination.
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Event Description
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See initial report.
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Search Alerts/Recalls
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