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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. STOCKERT HEATER-COOLER 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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SORIN GROUP USA, INC. STOCKERT HEATER-COOLER 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802); Fatigue (1849); Weakness (2145); Discomfort (2330); Complaint, Ill-Defined (2331)
Event Date 06/07/2011
Event Type  Death  
Event Description
This patient had a cabg on pump procedure five years ago.About 4 years and 9 months later, the patient was noted with complaint of general malaise, weakness, fatigue and poor oral intake.Blood cultures were obtained on the next day and were positive for mycobacterium avium complex.Additional testing of blood cultures is being conducted.The patient later expired 5 months after presenting with symptoms.
 
Event Description
This patient had a cabg on pump procedure 5.5 years ago.About 4 years and 9 months later, the patient was noted with complaint of general malaise, weakness, fatigue and poor oral intake.Blood cultures were obtained on the next day and were positive for mycobacterium avium complex.Additional testing of blood cultures is being conducted.The patient later expired 5 months after presenting with symptoms.
 
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Brand Name
STOCKERT HEATER-COOLER 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 w. 65th way
arvada CO 80004
MDR Report Key6331501
MDR Text Key67461626
Report Number6331501
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 Other
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2016
Event Location Hospital
Date Report to Manufacturer12/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
REPORT IS BEING SUBMITTED BECUASE OF THE CDC NOTIF; REPORT IS BEING SUBMITTED BECUASE OF THE CDC NOTIF
Patient Outcome(s) Death;
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