MAUDE Adverse Event Report: HEATING/COOLING DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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

Patient Problem Bacterial Infection (1735)

Event Date 05/20/2020

Event Type  Injury  

Event Description

Patient had cardiac surgery/aortic valve replacement in (b)(6) 2018; discovered to have mycobacterium chimaera bloodstream infection/endocarditis in (b)(6) 2020."? if related to heater/cooler devices associated w/ m.Chimaera during that time frame." patient had initial cardiac surgery at (b)(6) medical center in (b)(6).Please contact them for further details of heating/cooling devices being used in the operating room at that time.Fda safety report id# (b)(4).

• Brand Name: HEATING/COOLING DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• MDR Report Key: 10183939
• MDR Text Key: 196298936
• Report Number: MW5095153
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): Y
• 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: 06/18/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 64