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

Model Number 16-02-85

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Field service technician dispatched to the facility did not confirmed the issue.During troubleshooting he found that the temperature on patient side was unstable due to a defective temperature probe and the associated error code was displayed.To solve the issue the part was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.It cannot be ruled out that a defective temperature probe resulted in circuit shutdown as protection function against device component fault.

Event Description

Livanova (b)(4) received a report that when a heater-cooler system 3t is turned on, the patient circuit turned off by itself.There was no patient involvement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada 80004
• MDR Report Key: 11019602
• MDR Text Key: 221824433
• Report Number: 9611109-2020-00691
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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