LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problem
Death (1802)
|
Event Date 12/29/2015 |
Event Type
Death
|
Manufacturer Narrative
|
There was no patient involvement.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) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova (b)(4) initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova (b)(4) received a report, that a (b)(6) year old patient (initial (b)(6)) was found to be infected with a mycobacterium after an aortic valve and ascending aorta replacement.Allegation was made, that the device is possibly contaminated and is likely that the patient has been infected due to diffusion.The device has been removed from service.The patient has deceased.
|
|
Search Alerts/Recalls
|
|
|