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

Catalog Number 16-02-82

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Patient had aortic valve replacement (b)(6) 2014 where a sorin 3t heater cooler device was used during this surgery and developed discitis/osteomyelitis of t11/12 with biopsy that confirmed m chimera (b)(6) 2017 and also has prosthesis valve endocarditis showed on tee.

• Brand Name: SORIN 3T HEATER COOLER
• Type of Device: SORIN 3T HEATER COOLER
• Manufacturer (Section D): SORIN GROUP; munchen, lindberg 80939 ; GM 80939
• MDR Report Key: 6497025
• MDR Text Key: 73018956
• Report Number: MW5069099
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 77 YR
• Patient Weight: 85