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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. STOCKERT 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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SORIN GROUP USA, INC. STOCKERT 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Contamination (1120)
Patient Problems Purulent Discharge (1812); Sepsis (2067)
Event Date 10/23/2014
Event Type  Injury  
Event Description

The patient underwent cabg x 3 approximately 28 months ago. Sorin heater/cooler was used during the procedure. Subsequent information released by the company indicates potential risk for developing post operative infections related to airborne transmission of acid-fast bacilli (afb). This patient was admitted to the hospital approximately 2 months ago for sepsis. Purulent drainage noted from prior sternal incision site. Culture positive for afb. Wound required debridement and vac dressing placement.

 
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Brand NameSTOCKERT 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 west 65th way
arvada, CO 80004
MDR Report Key5496623
MDR Text Key40208154
Report Number5496623
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/08/2016,03/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2016
Event Location Hospital
Date Report TO Manufacturer03/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/14/2016 Patient Sequence Number: 1
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