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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA PLC SORIN 3T HEATER-COOLER

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LIVANOVA PLC SORIN 3T HEATER-COOLER Back to Search Results
Model Number SYSTEM 3T
Device Problem Microbial Contamination of Device (2303)
Patient Problems Anemia (1706); Death (1802); Fall (1848); Hypoglycemia (1912); Unspecified Infection (1930)
Event Date 08/16/2016
Event Type  Death  
Event Description

On (b)(6) 2016, pt underwent an aortic valve replacement and coronary artery bypass graft procedure for severe aortic stenosis. On 10/13/2016, cdc published a health advisory: cdc advises hospitals to alert pts at risk from contaminated heater-cooler devices during cardiac surgery. At the time of the cdc evaluation we had 4 heater-cooler units, one of which (#3), was thought to be at greatest risk due to the date of manufacture. The pt diagnosed with m. Chimaera infection was operated on (b)(6) of 2016 with use of machine #3. Late in the fall of 2017, the pt developed failure-to-thrive, hypoglycemia and experienced falls. Work up included a bone marrow biopsy performed on (b)(6) 2017 due to progressive pancytopenia and presumed diagnosis of myelodysplastic syndrome. Pt had chronic anemia due to esrd and had leukopenia observed prior to his aortic valve replacement. Unfortunately, he experienced progressive deterioration and opted for palliative care. His bone marrow study revealed non-necrotizing granuloma on (b)(6) 2017 and he died on (b)(6) 2017.

 
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Brand NameSORIN 3T HEATER-COOLER
Type of Device3T
Manufacturer (Section D)
LIVANOVA PLC
20 eastbourne terrace
london W2 6L G
UK W2 6LG
MDR Report Key7421468
MDR Text Key105373785
Report Number7421468
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 User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/04/2016,04/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYSTEM 3T
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2018
Distributor Facility Aware Date03/09/2018
Device Age8 yr
Event Location Hospital
Date Report TO Manufacturer04/04/2018
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: 04/04/2018 Patient Sequence Number: 1
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