MAUDE Adverse Event Report: LIVANOVA SORIN GROUP PERFUSION SYSTEM; HEATER COOLER 3T DEVICES

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/07/2014

Event Type  Injury  

Event Description

This patient was identified as acquiring a mycobacterium chimaera infection likely associated with use of the sorin group perfusion system - heater cooler 3t devices.

• Brand Name: SORIN GROUP PERFUSION SYSTEM
• Type of Device: HEATER COOLER 3T DEVICES
• Manufacturer (Section D): LIVANOVA ; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 6093870
• MDR Text Key: 59772364
• Report Number: 6093870
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2014,11/02/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2016
• Distributor Facility Aware Date: 11/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other