MAUDE Adverse Event Report: SORIN GROUP USA, INC. 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER/COOLER 3T

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/04/2012

Event Type  Death  

Event Description

Patient previously reported with m.Chimaera infection from our hospital presumably due to heater cooler unit used during cardiac surgery, has now passed.This report is a "death report" for a previously reported incident, although i realize it may be duplicative.

• Brand Name: 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 7040609
• MDR Text Key: 92513065
• Report Number: 7040609
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HEATER/COOLER 3T
• Device Catalogue Number: 16-02-85
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR