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U.S. Department of Health and Human Services

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

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HEATING/COOLING DEVICE CONTROL, TEMPERATURE CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Complaint, Ill-Defined (2331); Malaise (2359)
Event Type  No Answer Provided  
Event Description

My husband had open heart surgery at (b)(6) in (b)(6) on (b)(6) 2015. A while later, he received a letter stating that he had possibly been exposed to (b)(6) via a heating/cooling device during the surgery. A few months later, he suddenly had two abscessed teeth that had to be pulled - after he was put on strong antibiotics. He had very good teeth before that. His health took a turn for the worse and he has not seen a well day since, going from one doctor and hospital to another and nobody can figure (out) what is wrong. The bypass even failed. He has all the symptoms on the list i found on your web site. I called (b)(6) back after he began to have ill effects and requested that he be tested to rule out ntm as he had so much illness unlike his usual state of health. I was told that they would end up getting everyone in for blood tests. I was busy trying to get help for my husband and hauling him from one place to another trying to get attention for whatever seemed to be wrong at the time. When i mentioned to any doctor the letter he had received from (b)(6), i was told, "oh, he doesn't have pneumonia. We did a chest x-ray. " they totally blew me off regarding ntm when i tried to explain. Meanwhile, (b)(6) just let it slide and never got back to us regarding the test they had a right to do. My husband had an exceptionally strong constitution until that time, but has been treated with antibiotics for first one thing and another, not getting well, until he is very ill now. And nobody knows what to test for. I am very upset that he was just dropped that way and never tested so that we could know it isn't the nontuberculous mycobacterium causing his health to fail. He is becoming seriously ill with no hope of treatment at this time. Please respond to my plea. My email address is (b)(6). His name is (b)(6). Our phone number is (b)(6) although we are out a lot trying to get medical attention for him. Contact (b)(6).

 
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Brand NameHEATING/COOLING DEVICE
Type of DeviceCONTROL, TEMPERATURE CARDIOPULMONARY BYPASS
MDR Report Key7717727
MDR Text Key115081910
Report NumberMW5078562
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 07/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2018
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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