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

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.

• Brand Name: SORIN 3T HEATER-COOLER
• Type of Device: 3T
• Manufacturer (Section D): LIVANOVA PLC; 20 eastbourne terrace; london W2 6L G; UK W2 6LG
• MDR Report Key: 7421468
• MDR Text Key: 105373785
• Report Number: 7421468
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM 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 FDA: 04/04/2018
• Distributor Facility Aware Date: 03/09/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 105