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 Date 11/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).Through follow-up communication livanova (b)(4) learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theatre at an estimated distance of about 5 meters and with the fan far from the surgery field.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 (b)(4) received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera, intracellulare and gordonae.The lab report has been provided.There is no known patient involvement.
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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: based on additional information provided through follow up communication under other contamination complaint from the same hospital, livanova learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theater at an estimated distance of about 2-3 meters and with the fan opposite to the patient.In addition, livanova learned that customer follows the ifu¿s indication except for the h2o2 check, the device is always in the or and customer doesn¿t want to do the verification in the sterile room.As per instruction for use, h2o2 level must be checked daily and the customer practice is not in accordance with the instruction for use.This deviation may have led/contributed to the reported contamination.
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