LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 16-02-85 |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problems
Bacterial Infection (1735); Fatigue (1849); Pain (1994); Blurred Vision (2137); Chills (2191); Sweating (2444)
|
Event Date 01/10/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient identifier was not provided.Patient weight was not provided.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).Through follow-up communication livanova (b)(4) learned that the heater-cooler system 3t was not tested if it is contaminated.It was reported that the device was placed inside the operation theatre, far away and with the fan positioned away from the operation table.Further samples were taken from the patient but it was not possible to confirm the infection.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
|
On (b)(6) 2017, livanova (b)(4) received a user medwatch report ((b)(4)) which indicates that a patient is potentially infected with mycobacterium chimaera.The patient underwent a coronary artery bypass grafting on (b)(6) 2017 and a heater-cooler system 3t was used during the procedure.In (b)(6) 2017 the patient developed night sweats, fatique, back pain, chills and blurry vision.
|
|
Manufacturer Narrative
|
Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).Through follow-up communication livanova (b)(4) learned that the patient was discharged pending of additional cultures, afb+.Additional samples were taken.A review of the shr did not identify any deviations or non-conformities relevant to the reported issue.Since the patient has decided to proceed with an attorney, the hospital will have no more communication with the patient.No further investigation is therefore possible.In the event of receipt of new information, a supplemental report will be provided.Corrective actions are in progress for this issue.Device not returned.
|
|
Search Alerts/Recalls
|
|
|