Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 (b)(4).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 with mycobacterium gordonae.There is no known patient involvement.
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Manufacturer Narrative
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H.10: through follow-up communication under recent similar complaints from the same hospital livanova learned that the device is cleaned regularly according to the instruction for use and positioned outside the operating theatre during use.However, livanova learned that hydrogen peroxide h2o2 level is not checked daily as prescribed by the ifu and that is not monitored during period of non use even if the device is stored full of water.This is not in accordance with device instruction for use and this deviation may have led/contributed to the reported contamination.
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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: originally it was communicated to livanova that the device was contaminated with m.Gordonae.Through follow-up communication livanova retrieved the laboratory report.Analysis of the provided report show that the device was contaminated with m.Gordonae and paragordonae.
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Event Description
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See initial report.
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Search Alerts/Recalls
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