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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN STOCKERT SYSTEM 3T HEATER-COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND GMBH SORIN STOCKERT SYSTEM 3T HEATER-COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/14/2017
Event Type  Injury  
Event Description
Patient underwent aortic valve replacement and repair of aortic aneurysm in (b)(6) 2017, during which a sorin 3t heater-cooler was used.The heater cooler was purchased in 2012 and maintained according to manufacturer's ifu.In late (b)(6) 2022, reporter received notice that patient had been diagnosed with a non-tuberculosis mycobacterium (ntm)infection (m.Chimaera) by an outside hospital.The unit was not used after july 2018 and was returned to the manufacturer in 2019.Fda safety report id# (b)(4).
 
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Brand Name
SORIN STOCKERT SYSTEM 3T HEATER-COOLER
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
MDR Report Key13808414
MDR Text Key287538976
Report NumberMW5108227
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
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number16-02-85
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/01/2019
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient SexMale
Patient Weight63 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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