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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP, USA SORIN (LIVONOVA) GROUP, USA HEATER COOLER SYSTEM 3T

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SORIN GROUP, USA SORIN (LIVONOVA) GROUP, USA HEATER COOLER SYSTEM 3T Back to Search Results
Model Number 3T
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Other  
Event Description

Bacteria can contaminate the sorin heater cooler units used in conjunction with cardiopulmonary bypass machines. Water samples were taken as per the (b)(6) advisory alert. As per the (b)(6) advisory - this is being reported to the fda watch and the manufacturer.

 
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Brand NameSORIN (LIVONOVA) GROUP, USA
Type of DeviceHEATER COOLER SYSTEM 3T
Manufacturer (Section D)
SORIN GROUP, USA
14401 w 6th way
arvada CO 80004
MDR Report Key5719944
MDR Text Key47245223
Report Number5719944
Device Sequence Number1
Product Code DWC
Combination Product (Y/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 05/27/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
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 FDA05/27/2016
Event Location Hospital
Date Report TO Manufacturer05/27/2016
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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