MAUDE Adverse Event Report: LIVANOVA 3T HEATER COOLER HEATER SYSTEM

Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Type  Death  

Event Description

Caller reported that her late husband had a heart valve replacement surgery on (b)(6) 2011 during which the 3t heater cooler was used.He died on (b)(6) 2017 and an autopsy report stated that the cause of death was a rare bacterial lung infection.Testing for the autopsy was done on his body tissue but his blood was never tested.The caller also reported that prior to her husband's death, they received a letter from the (b)(4) notifying them that the 3t heater cooler device that was used during the surgery was contaminated with microbacterium chimaera.

• Brand Name: 3T HEATER COOLER HEATER SYSTEM
• Type of Device: 3T HEATER COOLER HEATER SYSTEM
• Manufacturer (Section D): LIVANOVA
• MDR Report Key: 7224448
• MDR Text Key: 98529694
• Report Number: MW5074915
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death