LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Date 01/06/2014 |
Event Type
Death
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Manufacturer Narrative
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D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.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.G.5.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.This report was due on november 29, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.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 deutschland received, through a lawsuit, a report that a male patient undergone surgery on (b)(6) 2013 was found infected by mycobacterium chimaera and died on (b)(6) 2021.Heater-cooler system 3t was used during surgery.Based on current status of the investigation the alleged device issue was not confirmed yet.
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Manufacturer Narrative
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Though follow up, livanova was informed following additional information added: -the surgery date: (b)(6) 2014.Possibly involved sns are (b)(6).Legal lawsuit has been issued and no other information has been made available other than that reported in the complaint file.For sn (b)(6) and (b)(6).It is not deemed necessary to perform dhr review since were manufactured in 2001 and 2004 respectively, while allegged surgery issue occurred in 2014 and contribution of possible native defects can be expected during first usages.Source of patient contamination remains unknown and the livanova device involvement as well.Livanova already implemented a strategy to decrease the probability of bacteria grow in the hc device by applying multiple measures implemented over the past few years through dedicated capa and field action.No device between the ones possible involved and in use at the hospital at the time of surgery (2014), was equipped with vacuum and sealing kit since upgrade activity started in 2017.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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