• 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 USA, INC STOCKERT HEATER COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

  • 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 USA, INC STOCKERT HEATER COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16S1238416-02-85
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Weakness (2145); Weight Changes (2607)
Event Date 07/27/2015
Event Type  Injury  
Event Description

Original procedure was aortic aneurysm repair. Hospital became aware of patient's infection earlier this month. Patient presented with weight loss and generalized weakness. Blood cultures taken and results have now been identified as m. Avium complex. No final outcome for case, but patient continues to feel poorly and may require additional surgical intervention. The units are the same as previously reported. Manufacturer response for heater cooler unit, stockert heater cooler system 3t (per site reporter). None at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTOCKERT HEATER COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA, INC
14401 west 65th way
arvada CO 80004
MDR Report Key7960646
MDR Text Key123567209
Report Number7960646
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2018
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL Number16S1238416-02-85
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2018
Device Age4 yr
Event Location Hospital
Date Report TO Manufacturer10/12/2018
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: 10/12/2018 Patient Sequence Number: 1
-
-