MAUDE Adverse Event Report: LIVA NOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH) SORIN 3T; HEATER-COOLER SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/11/2017

Event Type  Injury  

Event Description

Seven patients presented with similar sternal wound infections following cardiothoracic surgeries requiring bypass.Suspected, but yet unconfirmed correlation to perfusion device usage while in the operating room.

Event Description

Add'l info received from reporter for report mw5071896 on 12/06/2017: 11 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: HEATER-COOLER SYSTEM
• Manufacturer (Section D): LIVA NOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH); 20 eastbourne terrace; london W2 6L G; UK W2 6LG
• MDR Report Key: 6838512
• MDR Text Key: 84614546
• Report Number: MW5071896
• 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,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• 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: 4 MO
• Patient Weight: 5