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 09/23/2022 |
Event Type
malfunction
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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 and 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 milano, italy.Through follow-up communication livanova learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theater during use with the fan directed away from the patient and at an estimated distance of two (2) meters from the surgery field.In addition, it was learned that the hospital does not use re-usable heating blankets, that the h2o2 level is checked daily as per device instruction for use and that the device is stored drained when it is not used.Moreover, a disposable pall-aquasafe water filter with an 0.2 ¿m membrane or equivalent performance filter is used for tap water.Prior to initial operation and prior to storing the heater-cooler the surfaces and water circuits are disinfected as per device instruction for use and the 3t aerosol collection set is replaced after the allowed use period.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 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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Event Description
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See initial report.
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Manufacturer Narrative
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Through follow-up communication, livanova learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theater during use with the fan directed away from the patient and at an estimated distance of two (2) meters from the surgery field.In addition, it was learned that the hospital does not use re-usable heating blankets, that the h2o2 level is checked daily as per device instruction for use and that the device is stored drained when it is not used.Moreover, a disposable pall-aquasafe water filter with an 0.2 m membrane or equivalent performance filter is used for tap water.Prior to initial operation and prior to storing the heater-cooler, the surfaces and water circuits are disinfected as per device instruction for use and the 3t aerosol collection set is replaced after the allowed use period.Review of livanova complaints database revealed no further contamination events notified by this customer since unit installation in 2019.Taking into account available information, it cannot be excluded that the source of contamination is related to location where device is used and remains unknown.
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