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

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

Patient Problem Bacterial Infection (1735)

Event Date 07/21/2017

Event Type  Injury  

Event Description

Reporter stated that a pt had surgery on (b)(6) 2016 to have micro valve repair.Pt was readmitted for sternal wound on (b)(6) 2017 and culture was obtained on (b)(6) and it came back positive for mycobacterium avium-intracellulare.Reporter stated he called the mfr and left a message, however, he has not gotten a call back yet.

• Brand Name: STOCKERT HEATER COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP / LIVANOVA USA, INC.
• MDR Report Key: 9744463
• MDR Text Key: 180738992
• Report Number: MW5093192
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR