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

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Livanova heater-cooler system 3t, ntm (nontuberculous mycobacteria) device contamination, zero known patient infections, first positive culture (b)(6) 2022.Fda safety report id (b)(4).

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYBASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 15855709
• MDR Text Key: 304423360
• Report Number: MW5113446
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1