LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number UNKNOWN |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.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.Device unknown.
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Event Description
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Livanova (b)(4) received a report that a male patient underwent aortic valve replacement surgery on (b)(6) 2018 and a heater-cooler system 3t was used.Reportedly, mycobacterium chimaera infection was diagnosed in (b)(6) 2020.
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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: the serial number of the device used during the surgery is unknown.A database research reveals that two units (both manufactured in 2015) are currently in use at the customer facility: model number: 16-02-85 ; serial number (b)(6).Model number: 16-02-85 ; serial number (b)(6).However, it could not be confirmed that one of these units was the one used during the surgery.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of 2018 surgery.Complaints database analysis revealed that no previous device contamination complaints have been reported by this hospital.No further information is available on this specific case.The root cause could not be determined.
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