• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP THE STOCKERT HEATER-COOLER SYSTEM (3T)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP THE STOCKERT HEATER-COOLER SYSTEM (3T) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 04/17/2015
Event Type  Death  
Event Description
Pt represented to our facility with what was later identified as non-tuberculosis mycobacterium infection after cardiac bypass surgery a year prior (original surgery at (b)(6) hospital). He died from complications of the infection. The exposure did not occur at our facility. We are referring the case given the suspicion that it fits with known similar cases.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHE STOCKERT HEATER-COOLER SYSTEM (3T)
Type of DeviceTHE STOCKERT HEATER-COOLER SYSTEM (3T)
Manufacturer (Section D)
SORIN GROUP
MDR Report Key6113154
MDR Text Key60366994
Report NumberMW5066126
Device Sequence Number1
Product Code DWC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event 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: 11/17/2016 Patient Sequence Number: 1
-
-