MAUDE Adverse Event Report: LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH) SORIN 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Post Traumatic Wound Infection (2447)

Event Date 08/11/2017

Event Type  Injury  

Event Description

Eleven pts with confirmed mycobacterium abscessus sternal wound infections following cardiothoracic surgeries and use of sorin 3t heater-cooler unit.Two add'l pts with suspected mycobacterium abscessus infection were also treated accordingly.Therapy date: (b)(6) 2017.Diagnosis for use: cardiothoracic surgery requiring bypass.Age of device: 2 years.Ref # (b)(4).

• Brand Name: SORIN 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH); 20 eastbourne tr.; london W2 6L G; UK W2 6LG
• MDR Report Key: 7096114
• MDR Text Key: 94221685
• Report Number: MW5073831
• Device Sequence Number: 0
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 89