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U.S. Department of Health and Human Services

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

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SORIN GROUP USA, INC. 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3T
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem Bacterial Infection (1735)
Event Date 12/31/2014
Event Type  Malfunction  
Event Description

Patient underwent 2 open heart surgery procedures during which time a sorin heater-cooler system was used intraoperatively. Eight weeks later, an afb blood culture was collected and m chimaera was identified about 3 weeks later. This facility is unable to confirm that the ntm infection can be directly related to the use of the sorin heater-cooler system.

 
Event Description

Patient underwent 2 open heart surgery procedures about 2 years ago during which time a sorin heater-cooler system was used intraoperatively. Fourteen months later, an afb blood culture was collected and m. Chimaera was identified about 3 weeks later. This facility is unable to confirm that the ntm infection can be directly related to the use of the sorin heater-cooler system.

 
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Brand Name3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 west 65th way
arvada, CO 80004
MDR Report Key5655569
MDR Text Key45199623
Report Number5655569
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,Followup
Report Date 05/06/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number3T
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2016
Event Location Hospital
Date Report TO Manufacturer05/06/2016
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

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