MAUDE Adverse Event Report: SORIN GROUP / LIVANOVA DEUTSCHLAND GMBH SORIN 3T HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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

Patient Problem Bacterial Infection (1735)

Event Date 10/03/2014

Event Type  Injury  

Event Description

Pt had an aortic valve replacement and had a sorin 3t heater cooler used during her surgery.Developed mycobacteria chimera infection.Taken back to surgery (b)(6) 2017 for debridement and sternal wire removal.Fda safety report id# (b)(4).

• Brand Name: SORIN 3T HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP / LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 8864703
• MDR Text Key: 153534692
• Report Number: MW5088766
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 66 YR
• Patient Weight: 83