LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 16-02-80 |
Device Problem
Device Contamination With Biological Material (2908)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/01/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
There is no known patient involvement.The exact event date was not provided.However, the customer stated that the samples were dated (b)(6) 2017.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).This medwatch report is being filed on behalf of livanova (b)(4).The customer reported that a disinfection cycle has been performed and the contamination was able to be removed from the device.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
|
|
Event Description
|
Livanova (b)(4) received a report that contamination was identified in a heater-cooler system 3t.The type of contamination is unknown at this time.There is no known patient involvement.
|
|
Manufacturer Narrative
|
Livanova (b)(4) received the laboratory results, but due to mold within the device the kind of contamination could not be evaluated.Through follow-up communication with the customer, livanova (b)(4) learned that the device was placed inside the operation theater approximately 1 to 1.5 meters away from the patient field.The customer reported that the cleaning protocol recommended by livanova has been applied since the devices were put into service.However, it was reported that water controls were not conducted every month due to cost.In october 2017, a new water test was performed on the device and the lab test revealed that the contamination is no longer present.Corrective actions are in progress for this issue.
|
|
Search Alerts/Recalls
|
|
|