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

Model Number 16-02-85

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed during procedure an error message (unknown code) on patient pump 2 side.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow-up communication livanova learned that error code that appeared was e22, associated to patient circuit 2 pump blocked or too slow.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to solve the issue, patient pump 2 was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2012.Based on the information collected and the technical intervention done, it cannot be ruled out that the most likely root cause of the reported event can be traced back to an accumulation of dirt/humidity, probably due to environmental conditions (high temperatures and condensation) in which the pump worked, leading to a mechanical issue of the pump.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18381748
• MDR Text Key: 331489025
• Report Number: 9611109-2023-00655
• 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,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• 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