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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH) SORIN 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH) SORIN 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Contamination (1120)
Patient Problems Abscess (1690); Post Traumatic Wound Infection (2447)
Event Date 08/11/2017
Event Type  Injury  
Event Description

Eleven pts with confirmed mycobacterium abscessus sternal wound infections following cardiothoracic surgeries and use of sorin 3t heater-cooler unit. Add'l pts with suspected mycobacterium abscessus infection were also treated accordingly. Therapy date: (b)(6) 2017. Diagnosis for use: cardiothoracic surgery requiring bypass. Ref # (b)(4).

 
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Brand NameSORIN 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH)
20 eastbourne terrace
london W2 6L G
UK W2 6LG
MDR Report Key7096112
MDR Text Key94220431
Report NumberMW5073830
Device Sequence Number0
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2017
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/30/2017 Patient Sequence Number: 1
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