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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEATER-COOLER DEVICE FROM OPEN HEART SURGERY

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HEATER-COOLER DEVICE FROM OPEN HEART SURGERY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802); Erythema (1840); Fatigue (1849); Nausea (1970); Vomiting (2144); Weakness (2145); Myalgia (2238); Arthralgia (2355); Weight Changes (2607)
Event Date 06/13/2012
Event Type  Death  
Event Description
"question," open heart surgery will give you 5 to 10 more years with a better quality of life, instead decline in health rapidly. Infections, vomiting, nausea, fatigue, muscle and joint pain, weakness, weight loss, redness and heat never went away a surgery site. I contacted (b)(6) hospital in (b)(6). After receiving a letter about this bacteria. I was told that because my husband had died, nothing could be done and they didn't think even with the problems he had that this was the problem because it is rare.
 
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Brand NameHEATER-COOLER DEVICE FROM OPEN HEART SURGERY
Type of DeviceHEATER-COOLER DEVICE FROM OPEN HEART SURGERY
MDR Report Key6328493
MDR Text Key67467162
Report NumberMW5067850
Device Sequence Number1
Product Code DWC
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 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
Treatment
ICD; MANY PRESCRIPTIONS
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