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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 Nonstandard Device (1420)
Patient Problem No Information (3190)
Event Date 10/19/2016
Event Type  Malfunction  
Event Description

Cdc has issued a mandatory recall of sorin 3t heater cooler devices. Manufacturer response for 3t heater cooler, sorin (per site reporter): cdc recall.

 
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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 Key6088830
MDR Text Key59469068
Report Number6088830
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 10/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number3T
Device Catalogue Number16-02-85
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2016
Device Age3 yr
Event Location Hospital
Date Report TO Manufacturer10/21/2016
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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