MAUDE Adverse Event Report: SORIN GROUP SORIN 3T HEATER COOLER SYSTEM

Catalog Number 16-02-82

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 06/26/2015

Event Type  Injury  

Event Description

Pt had an aortic valve replacement with hemiarch replacement.Had sorin 3t heater cooler device used on him and developed mycobacteria chimaera infection.

• Brand Name: SORIN 3T HEATER COOLER SYSTEM
• Type of Device: SORIN 3T HEATER COOLER SYSTEM
• Manufacturer (Section D): SORIN GROUP; lindberg; munchen 80939 ; GM 80939
• MDR Report Key: 6590276
• MDR Text Key: 76029005
• Report Number: MW5070015
• Device Sequence Number: 1
• Product Code: DWC
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-82
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 59