LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number UNKNOWN |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/14/2022 |
Event Type
malfunction
|
Event Description
|
On 30 november 2022, livanova has received the medwatch5113446 informing livanova that an heater-cooler system 3t was found contaminated with ntm (nontuberculous mycobacteria).There was no patient involvement.
|
|
Manufacturer Narrative
|
There was no known patient involvement.The model, sn and udi of the device have not been provided.Since the sn of the device has not been provided, the manufacturing date is unknown.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 united states.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
H10: analysis of all the service activities performed at this customer facility over recent years revealed that three (3) different units were installed: part number 16-02-85, serial numbers (b)(6).Through follow-up communication with a livanova field service representative, it was learned that all the units above mentioned are any longer at customer facility since beginning of 2023.No additional data about this complaint could be retrieved since these units have been out of service for months.Review of complaints database identified no other previous contamination events of heater cooler 3t devices occurred at the involved customer facility.Based on the information available, source of device contamination could not be clearly established and remains unknown.
|
|
Search Alerts/Recalls
|
|
|