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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN HEATER COOLER DEVICE

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SORIN SORIN HEATER COOLER DEVICE Back to Search Results
Model Number 3T
Device Problems Contamination (1120); Product Quality Problem (1506)
Patient Problem Unspecified Infection (1930)
Event Date 09/30/2016
Event Type  Injury  
Event Description
M. Chimaera isolated from wound culture from pt after left ventricular assist device (lvad) on (b)(6) 2016. Lvad placed on (b)(6) 2015, 3t heater cooler device used during surgery.
 
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Brand NameSORIN
Type of DeviceHEATER COOLER DEVICE
Manufacturer (Section D)
SORIN
de
MDR Report Key6099531
MDR Text Key59786958
Report NumberMW5066012
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3T
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/10/2016 Patient Sequence Number: 1
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