MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.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.

Event Description

Livanova received a medwatch importer report (b)(4) stating that in (b)(6) 2017, a patient undergone a cardiac surgery and he was recently identified positive to mycobacterium chimaera.A heater-cooler system 3t was used during the surgery.Within the report are stated other information about the patient that may have influenced the outcome of the event: interstitial pulmonary fibrosis diagnosed around 7 years.He presented to clinic with weight gain, peripheral edema, cough and increased dyspnea on exertion.In the past, he has had prolonged carbon silicon exposure.

Manufacturer Narrative

H.10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A service history review did not reveal any relevant information.As forecast by livanova process, the unit was deep disinfected and the upgrade was completed on october, 2019.A complaint database analysis revealed that no device contamination complaints were ever submitted by this hospital.Moreover, the reported serial number was not even manufactured at the time the surgery took place and it was installed at the (b)(6)hospital in october, 2017 thus, based on the provided information, an involvement of this specific device can be excluded.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9737539
• MDR Text Key: 194012505
• Report Number: 9611109-2020-00119
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1