MAUDE Adverse Event Report: LIVANOVA/SORIN GROUP USA, INC. STOCKERT HEATER COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

The risk management department was informed this patient had cultures positive for ntm bacteria growing from his sternal incision site.(mycobacterium chimaera) the patient had undergone a cabg about 3 years ago which was in the window of time that a number of sternal would infections were identified.These are believed to be related to issues involving the sorin heater cooler device used during open chest procedures.

• Brand Name: STOCKERT HEATER COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA/SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 7262978
• MDR Text Key: 99793053
• Report Number: 7262978
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018,02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: ASSET TAG 536412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR