LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-85 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Date 04/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.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).The device serial number used during surgery is unknown.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 received report that a male patient underwent cardiac transplant on (b)(6) 2019 and an heater-cooler 3t system was used.Reportedly, patient showed signs of infection beginning in the fall of 2020 and diagnosed with chorioretinitis and later developed anorexia, fatigue, lightheadedness, dizziness, blurred vision, a (b)(6) weight loss, and a lesion on his sternal incision.On (b)(6) 2021, underwent an operation to evaluate his sternal lesion.Three sternal wires were removed and the wound was drained and sent for acid fast bacilli testing.This testing showed cutibacterium and m.Chimaera.Patient is still undergoing treatment.
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Manufacturer Narrative
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H.10: no dhr and shr could be performed since no serial number was provided.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery.Through follow-up communication with the chief perfusionist under previous cases from the same hospital, livanova deutschland learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices in use at the hospital are very clean and there is no sign of biofilm.The devices are located inside the operating theater during use.The result of microbial sampling performed at customer site revealed that two devices in use at the hospital were found to be contaminated.It is not possible to determine if the device used for this specific surgery was one of the two devices confirmed to be contaminated.A relationship between device and reported event could not be determined.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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See initial report.
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