LIVANOVA DEUTSCHLAND GMBH 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
No Known Impact Or Consequence To Patient (2692)
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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.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: k052601).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).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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Through media monitoring livanova learned of an infection of a patient with m.Chimaera.In the paper article it is stated that the patient had started to feel ill during 2019 showing increasing weakness, a high weight loss, some fever.The infected patient, hospitalized in the last few months at (b)(6), has now been discharged to continue antibiotic therapy at home.
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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: further information has been requested to the hospital in order to confirm/deny the news.Despite the attempts, the hospitals did not provide any feedback to livanova.Thus, no further investigation is possible.
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