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
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.The laboratory report confirming the reported contamination has been provided to livanova.The customer required deep disinfection to solve the reported contamination.There was no patient injury.
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Manufacturer Narrative
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There was no 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: k191402).Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in torino, italy.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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Livanova received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.No patient/user affected.The laboratory report test confirming the reported contamination has been provided to livanova.Through follow-up communication, livanova learned that the device was cleaned regularly per the instruction for use and the water quality monitoring is applied and the h2o2 checked every day.A disposable pall-aquasafe water filter with an 0.2m membrane for tap water or equivalent performance filter is used and when the device is not used, it is stored drained.The hospital does not use reusable heating blankets.Prior to initial operation and prior to storing the heater-cooler the surfaces and water circuits are disinfected and device surfaces also after every operation.3t aerosol collection set is replaced after the allowed use period.The device is placed outside the operation theatre during use.Source of contamination is related to location where device is used and remained unknown.
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Event Description
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See initial report.
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