LIVANOVA DEUTSCHLAND HEATER COOLER 3T (230 VOLT); 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 11/29/2022 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-coolersystem 3t was contamination by chimaera.There is no patient involvement.The customer has requested deep disinfection.
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Manufacturer Narrative
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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).Correction/removal number: 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 belgium.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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Through follow-up communication with the customer, livanova was informed that the device is not cleaned regularly according to the instruction for use "aquaconservans" are being used to fill up the device instead of water.Daily h2o2 level check is not performed and h2o2 is not added when the water in the tanks is changed, in disagreement with ifu.Other devices/surfaces in the or/icu were not tested to investigate presence contamination.The sink water has not been tested to investigate presence of mycobacterium contamination the hospital does not use a medical tap filter or any kind of filter.The water circuits are not disinfected prior device storage.The device surfaces are not cleaned prior to use or storage.No information was available regarding the use of blankets, water quality hpc and ntm monitoring and replacement frequency of the aerosol collection.The device is placed outside the operating theater during use and is drained when not in use.Disposable gloves were used only for device cleaning.The heater cooler is not used in connection with other devices.The device operates in connection to a vacuum source during surgery and the vacuum is applied until patient leaves the operating room.The field blue tubing set is replaced every year.The root cause of the contamination could not be determined.It is likely that the deviation from the instruction for use may have led/contributed to the reported contamination.
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Event Description
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See intial report.
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