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 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.G.5.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).H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in hudson, florida.Livanova initiated an investigation.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 chelonae both pre (31 cfu/ml) and post-disinfection procedure (12 cfu/ml).The laboratory report confirming the reported contamination has been provided to livanova.The unit has been taken out of service by the customer.There is no report of patient injury.
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Manufacturer Narrative
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H10: through follow-up communication livanova learned that the unit is cleaned regularly according to the instructions for use and is placed inside the operating room, with the fan positioned opposite to the patient at an estimated distance of about two (2) meters from the surgery field.The h2o2 level is daily checked when the device is being used.When the device is not used, it is stored full of water but the h2o2 daily check is not executed during weekends.No patient reusable heating blankets are used by the hospital and the 3t aerosol collection set is replaced after the allowed use period.A disposable pall-aquasafe water filter with a 0.2 m membrane is used for tap water.Based on information collected, it cannot be excluded that the deviation from device instructions for use identified relating to the missed daily check of h2o2 during weekends when the device is stored full of water, may have caused or contributed to reported contamination.
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Event Description
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See initial report.
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