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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN 3T HEATER AND COOLER

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LIVANOVA DEUTSCHLAND GMBH SORIN 3T HEATER AND COOLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Dyspnea (1816); Fainting (1847); Fatigue (1849); Vomiting (2144); No Code Available (3191)
Event Date 03/04/2018
Event Type  Malfunction  
Event Description

At the time of the surgery and intraoperatively, there were no concerns or issues with the sorin 3t. Fainted three times in (b)(6) on different days. At this time pt also had significant fatigue and shortness of breath with exertion that pt though was secondary to asthma. In (b)(6) pt began to have diarrhea, vomiting, and stomach pain and presented to the ed. Pt was discharged home with zofran. One week later pt's vomiting persisted and re-presented to the ed where an echo was performed and was found to have severe dilated cardiomyopathy and acalculous cystitis. Serial echo demonstrating poor cardiac output with ef less than 12% and pt was ultimately listed as needing heart transplant. An lvad was required due to his rapid decompensation along with intubation.

 
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Brand NameSORIN 3T
Type of DeviceHEATER AND COOLER
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
14401 west 65th way
arvada CO 80004
MDR Report Key9488399
MDR Text Key171826723
Report Number9488399
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location Hospital
Date Report TO Manufacturer12/18/2019
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? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/18/2019 Patient Sequence Number: 1
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