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 mw#(b)(4) stating that around 8 months ago 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.Differently from what stated in the event description, (b)(6) 2018 is reported as event date within the report.Within the report are stated other information about the patient that may have influenced the outcome of the event: drug induced interstitial pulmonary fibrosis, coronary arterial disease, hyperlipidemia, benign prostatic hypertrophy, retroperitoneal carcinoma, zoster.

Event Description

See initial report.

Manufacturer Narrative

H.10: a service history review did not reveal any relevant information.The unit was deep disinfected as regular service for the upgrade completed on october, 2019.A complaint database analysis has been performed and revealed that no device contamination complaints were ever submitted by this hospital.

• 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: 9737542
• MDR Text Key: 191168177
• Report Number: 1718850-2020-01012
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1