Model Number 16-02-82 (OR) 16-02-81 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problems
Bacterial Infection (1735); Foreign Body In Patient (2687)
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Event Date 04/18/2016 |
Event Type
Death
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Manufacturer Narrative
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Patient related information is not provided.Part number and serial number of the device in question not provided.Date of manufacturing unavailable as the serial number is unknown.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of the heater-cooler system 3t devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).During a preliminary communication, livanova (b)(4) learnt that the hospital was continuing to use the affected unit.A replacement unit was ordered and is awaited for delivery.The hospital follows all instructions emphasised by the manufacturer in the instructions for use, in maintaining and cleaning the heater-cooler 3t.Additionally, the hospital declared that they have also implemented safety measures to further minimize risk to the patients while using the heater-cooler system 3t, although no further details were provided.The device was not tracked during the time of surgery thereby the serial number not being available.The unit has been upgraded with the vacuum system onsite.The investigation is ongoing.Corrective actions are in progress for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that on december 2017, a patient was confirmed to be tested positive for m.Chimaera post cardiovascular surgery in (b)(6) 2016.The heater-cooler 3t was used during the cardiovascular surgery.Patient is recovering in the hospital.
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Event Description
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See initial report.
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Manufacturer Narrative
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Through media monitoring livanova became aware of a newspaper article mentioning ten (10) confirmed cases of patient infections in (b)(6).All 10 infections in (b)(6) are captured in livanova complaints database and the article has been evaluated for missing additional information for each specific case.Within the article it is specified that 8 patients died and that the other 2 are alive.Based on details such as surgery date, livanova has been able to trace some information to this specific event.Within the article it is stated that the patient underwent cardiac surgery in (b)(6) 2016 as already reported in the initial report.In addition, the article states that the patient died as a result of m.Chimaera infection in (b)(6) 2018, two months after doctors confirmed he'd been infected.By then, it had spread to his bone marrow and his brain.The patient was (b)(6) years old.Thus, the event outcome for this case has been updated as death.No device was upgraded with vacuum and sealing kit at the time of 2016 surgery.
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Event Description
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See intial report.
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Manufacturer Narrative
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Through follow up, livanova was informed of a more detailed event description: patient underwent an aortic valve replacement and aortic aneurysm repair on (b)(6) 2016.Patient was later diagnosed with a disseminated m.Chimaera infection and died on (b)(6) 2018 (age 76 years old).No evidence to suggest device failed to meet specifications is available no records confirming the use of a 3t or specifically identifying a 3t have been produced to date.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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