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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOPULMONARY BYPASS HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS HEATER COOLER

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CARDIOPULMONARY BYPASS HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS HEATER COOLER Back to Search Results
Device Problem Contamination (1120)
Patient Problems Bacterial Infection (1735); Stroke/CVA (1770); Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Event Date 07/08/2016
Event Type  Death  
Event Description

Reporter on behalf of her father (b)(6) states that on (b)(6) 2016 her father underwent an aortic valve replacement procedure where the cardiopulmonary heater/cooler device was used. Patient did well until (b)(6) morning (b)(6) 2016 where patient called her notifying her of his condition worsening. He was unable to sit-up and his blood pressure was declining. Upon arrival to the er patient suffered a massive heart attack. Patient survived and blood cultures were run. A bacterial growth infection was discovered under the heart valve. Reporter states that the infection was caused by the cardiopulmonary heater cooler device. Patient remained in the hospital until (b)(6) 2017 when he was moved to hospice care. Patient died on (b)(6) 2017. Cause of death was cva.

 
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Brand NameCARDIOPULMONARY BYPASS HEATER COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS HEATER COOLER
MDR Report Key6489351
MDR Text Key72792598
Report NumberMW5069050
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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: 04/11/2017 Patient Sequence Number: 1
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