MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Insufficient Cooling (1130)

Patient Problem Alteration in Body Temperature (4568)

Event Date 12/18/2020

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The device was properly functional.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on the available information, the reported death cannot be traced back to any device malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a medwatch report mw5098936 of a suspected cooling malfunction of heater-cooler system 3t patient circuit during a procedure.Reportedly, the device did not cool the blood as it was supposed to, due to a suspected issue with water flow through the machine.The device was replaced with another.Reportedly, the device was properly working after the procedure.The event outcome reported within the medwatch report mw5098936 is death.No relationship between device malfunction and patient death was stated within the provided report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 11453830
• MDR Text Key: 238879062
• Report Number: 9611109-2021-00114
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death