Model Number 16-02-80 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/23/2020 |
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 deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland 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 deutschland received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.The laboratory report confirming the reported contamination has been provided to livanova.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 cleaned regularly per the ifu, placed inside of the operation theater during use, with the fan away from the patient at an estimated distance from the surgery field of 2 meters.The device will be sent to the manufacturer site for deep disinfection in order to solve the reported issue.
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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 under previous complaints from the same hospital, livanova learned that the device was cleaned regularly per the ifu, placed outside the operation theater during use and not inside as previously reported.
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Event Description
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See initial report.
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Search Alerts/Recalls
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