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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA/ SORIN 3T HEATER-COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA/ SORIN 3T HEATER-COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems Device Reprocessing Problem (1091); Contamination (1120); Device Maintenance Issue (1379)
Patient Problem No Code Available (3191)
Event Date 01/13/2016
Event Type  Injury  
Event Description

Livanova (formally sorin) released updated ifus for cleaning and maintenance of their 3t heater-cooler device due to concerns of ntm outbreak risks. The device has been noted to have a "dead leg" from visual inspection that increases the risk of contamination due to stagnant water. Multiple attempts have been completed to get in contact with the mfr to remedy this risk in design, and to get recommendations for microbiologic testing.

 
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Brand Name3T HEATER-COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA/ SORIN
MDR Report Key5744456
MDR Text Key48119642
Report NumberMW5062977
Device Sequence Number0
Product Code DWC
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
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: 06/20/2016 Patient Sequence Number: 1
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