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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 HEATER-COOLER SYSTEM

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LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH) SORIN 3T HEATER-COOLER SYSTEM Back to Search Results
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 08/11/2017
Event Type  Injury  
Event Description

Seven patients presented with similar sternal wound infections following cardiothoracic surgeries requiring bypass. Suspected, but yet unconfirmed correlation to perfusion device usage while in the operating room. Dates of use: (b)(6) 2015 - (b)(6) 2017. Diagnosis or reason for use: cardiothoracic surgery requiring bypass. Event abated after use stopped or dose reduced: yes.

 
Event Description

Add'l info received on (b)(6) 2017 from reporter for mw5071891: (b)(4) pts with confirmed mycobacterium abscessus sternal wound infections following cardiothoracic surgeries and use of sorin 3t heater-cooler unit. Two add'l pts with suspected mycobacterium abscessus infection were also treated accordingly. Therapy date: (b)(6) 2017. Diagnosis or reason for use: cardiothoracic surgery requiring bypass. Approximate age of device: 2 years. (b)(4).

 
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Brand NameSORIN 3T
Type of DeviceHEATER-COOLER SYSTEM
Manufacturer (Section D)
LIVANOVA PLC (FORMERLY SORIN GROUP DEUTCHLAND GMBH)
20 eastbourne terrace
london W2 6L G
UK W2 6LG
MDR Report Key6838450
MDR Text Key84404299
Report NumberMW5071891
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 Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/01/2017 Patient Sequence Number: 1
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