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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP SORIN 3T HEATER COOLER UNIT

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SORIN GROUP SORIN 3T HEATER COOLER UNIT Back to Search Results
Device Problem Contamination (1120)
Patient Problems Bacterial Infection (1735); Fever (1858); Hepatitis (1897); Pneumonia (2011)
Event Date 12/12/2015
Event Type  Injury  
Event Description
Patient with history of rheumatic heart disease who had a mitral valve repair and annuloplasty in (b)(6) 2014, presented in (b)(6) 2015 with 3 weeks of fevers of unknown origin. Found to have nonviral (b)(6), developed pneumonia in hospital, found to have new vegetation on prosthetic mitral valve ring. Taken to operating room for valve replacement, and valve tissue had (b)(6). Tissue cultures subsequently grew mac/m. Chimaera. Sorin 3t heater cooler unit was used during patient's bypass for mitral valve reconstruction and annuloplasty on (b)(6) 2014.
 
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Brand NameSORIN 3T HEATER COOLER UNIT
Type of DeviceSORIN 3T HEATER COOLER UNIT
Manufacturer (Section D)
SORIN GROUP
IT
MDR Report Key5419455
MDR Text Key37786227
Report NumberMW5060052
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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

Patient Treatment Data
Date Received: 02/05/2016 Patient Sequence Number: 1
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