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U.S. Department of Health and Human Services

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

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HEATING/COOLING DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
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).
 
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Brand NameHEATING/COOLING DEVICE
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
MDR Report Key10183939
MDR Text Key196298936
Report NumberMW5095153
Device Sequence Number1
Product Code DWC
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/22/2020 Patient Sequence Number: 1
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