MAUDE Adverse Event Report: LIVANOVA PLC (FORMERLY SORIN GROUP DEUTSCHLAND GMB) SORIN 3T HEATER/COOLER DEVICE; TEMPERATURE CONTROLLER

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 03/18/2016

Event Type  Injury  

Event Description

Mycobacterium canariasense isolated from a pt who had open heart surgery and the sorin 3t heater/cooler device was used in the case.

• Brand Name: SORIN 3T HEATER/COOLER DEVICE
• Type of Device: TEMPERATURE CONTROLLER
• Manufacturer (Section D): LIVANOVA PLC (FORMERLY SORIN GROUP DEUTSCHLAND GMB)
• MDR Report Key: 6260437
• MDR Text Key: 65318140
• Report Number: MW5067285
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR