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 Type
Injury
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Manufacturer Narrative
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Patient information was not provided.Pma/510k: the heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Correction/removal number: 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 will attempt to obtain additional information.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 patient underwent a cardiac surgery (lvad) in (b)(6) 2019 and a heater-cooler system 3t was used.The patient underwent a second surgery in (b)(6) 2021 for lvad replacement and was informed to be infected with ntm.The patient is currently on antibiotic regimen.
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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: no dhr and shr could be performed since no serial number was provided.Through follow-up communication with the chief perfusionist under previous cases from the same hospital, livanova deutschland 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 in use at the hospital are very clean and there is no sign of biofilm.The devices are located inside the operating theater during use.The result of microbial sampling performed at customer site revealed that two devices in use at the hospital were found to be contaminated.It is not possible to determine if the device used for this specific surgery was one of the two devices confirmed to be contaminated and is not possible to retrieve the information if the device was already contaminated at the time of the surgery.No additional information has been provided regarding this specific case.The root cause of the event remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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