MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH LIVANOVA HEATER-COOLER SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16.02.85

Device Problem Microbial Contamination of Device (2303)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Liver Damage/Dysfunction (1954); Pneumothorax (2012); Ventilator Dependent (2395); Abdominal Distention (2601); Renal Impairment (4499); Lactate Dehydrogenase Increased (4567)

Event Date 12/14/2021

Event Type  Death  

Event Description

Patient with one month of exertional chest pain had work up confirming multi-vessel coronary artery disease.Patient had cardiac catheterization and echocardiogram which revealed ejection fraction (ef) of 45% and aortic valve sclerosis with mild aortic insufficiency.The patient underwent coronary artery bypass grafting (cabg) x 4 vessels, tolerated the procedure well and was admitted to the cardiovascular intensive care unit (cvicu) on 8mcg/min of norepinephrine.Patient had increasing vasopressor requirements over the next several hours, had right pneumothorax treated with chest tube and re-expansion of lung.Due to increasing hemodynamic instability, patient was unable to be weaned from the ventilator.There was noted escalating serum lactates, creatinine and liver function test (lft) labs.Early on pod (postoperative day) #1, noted abdominal discomfort and distention.Surgery was consulted, but no findings per ct for surgical intervention.Transthoracic echocardiogram confirmed good left ventricular (lv) function with no tamponade.Shock liver was suspected and supportive measures were in place, however liver dysfunction progressed.Continuous renal replacement therapy (crrt) was initiated however patient continued to decline leading to the decision that further medical treatment was futile and patient passed 4 days post operatively.One day prior to the patient passing, blood cultures were obtained from the patient and results revealed cupriavidus pauculus.Infectious disease staff were consulted and environmental testing was conducted.The bypass heater cooler #3 dependent clear tubing was cultured and found to be (b)(6) for the same cupriavidus pauculus.Please note hospital is in the process of contacting manufacturer as of report submission.

Event Description

Patient with one month of exertional chest pain had work up confirming multi-vessel coronary artery disease.Patient had cardiac catheterization and echocardiogram which revealed ejection fraction (ef) of 45% and aortic valve sclerosis with mild aortic insufficiency.The patient underwent coronary artery bypass grafting (cabg) x 4 vessels, tolerated the procedure well and was admitted to the cardiovascular intensive care unit (cvicu) on 8mcg/min of norepinephrine.Patient had increasing vasopressor requirements over the next several hours, had right pneumothorax treated with chest tube and re-expansion of lung.Due to increasing hemodynamic instability, patient was unable to be weaned from the ventilator.There was noted escalating serum lactates, creatinine and liver function test (lft) labs.Early on pod (postoperative day) #1, noted abdominal discomfort and distention.Surgery was consulted, but no findings per ct for surgical intervention.Transthoracic echocardiogram confirmed good left ventricular (lv) function with no tamponade.Shock liver was suspected and supportive measures were in place, however liver dysfunction progressed.Continuous renal replacement therapy (crrt) was initiated however patient continued to decline leading to the decision that further medical treatment was futile and patient passed 4 days post operatively.One day prior to the patient passing, blood cultures were obtained from the patient and results revealed cupriavidus pauculus.Infectious disease staff were consulted and environmental testing was conducted.The bypass heater cooler #3 dependent clear tubing was cultured and found to be positive for the same cupriavidus pauculus.Please note hospital is in the process of contacting manufacturer as of report submission.

• Brand Name: LIVANOVA HEATER-COOLER SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 13235731
• MDR Text Key: 283669912
• Report Number: 13235731
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16.02.85
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 30295 DA
• Patient Sex: Male
• Patient Weight: 83 KG