Model Number 16-02-85 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Date 11/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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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).Through further follow-up communication with the chief perfusionist livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm.The devices are located inside the operating theatre during use.We are currently waiting to know the result of microbial sampling performed at customer site.Reportedly the tests are still in progress.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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A male patient born on (b)(6) undergone a cardiac surgery on (b)(6) 2019.Patient resulted to be infected with m.Avium intracellulare complex at the sternal tissue.This patient infection was previously reported under importer (b)(4) and manufacturer (b)(4).Following to additional information received from the hospital a patients mapping has been done and separated cases have been created.
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Manufacturer Narrative
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Two (2) over five (5) devices which were in use at the hospital resulted to be contaminated.Only one serial number has been provided (b)(6) which is the device claimed in this specific case.A follow up report for the other cases associated to this specific device has been filed.The second serial number remains unknown as well as the type of contamination.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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