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U.S. Department of Health and Human Services

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

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SORIN GROUP SORIN 3T HEATER COOLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802); Renal Failure (2041); Loss of consciousness (2418); No Code Available (3191)
Event Date 04/08/2014
Event Type  Death  
Event Description

Patient underwent avr/mvr on (b)(6) 2014 and had a sorin 3t heater cooler used during his surgery. On (b)(6) 2017 readmitted to the hospital with a large vegetation on his valve. He had blood cultures taken and mycobacteria chimera grew out. He had delirium and worsening liver, kidney failure and dic. Patient became unresponsive and sister consulted and decision was made to withdraw treatment and have comfort measures only. Patient died (b)(6) 2017.

 
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Brand NameSORIN 3T HEATER COOLER
Type of DeviceHEATER COOLER
Manufacturer (Section D)
SORIN GROUP
muchen, lindberg 80939 DE
GM 80939 DE
MDR Report Key6479909
MDR Text Key72515780
Report NumberMW5068995
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/07/2017 Patient Sequence Number: 1
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