LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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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 03/20/2019 |
Event Type
Death
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Manufacturer Narrative
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Patient information was not provided.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 received report that a male patient underwent cardiac surgery on (b)(6) 2019 and an heater-cololer system 3t was used.The serial number of device used during surgery is unknown.The patient suffered numerous complications related to surgery, including cardiac and organ damage, vision problems, etc.And was unsuccessfully treated with antibiotics.Mycobacterium chimaera infection was reported.The patient passed away on (b)(6) 2021.
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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.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery.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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Event Description
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See initial report.
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