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 01/05/2021 |
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).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.The type of bacterium is still pending to livanova.Reportedly, the device has been removed from service and will be sent to livanova for deep disinfection to solve the reported contamination.A loaner device was provided to the customer.There is no known patient involvement.
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Manufacturer Narrative
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H.10: the reported event is a duplicate of another previous event which was already reported under reference 9611109-2021-00016.Therefore this specific complaint will be voided.
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Event Description
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See initial report.
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Search Alerts/Recalls
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