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

Model Number 16-02-85

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) minnesota.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix it, leaking sniffle valve 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.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t was leaking a large amount of water from the patient 1 circuit on the input side at the venting valve.The issue occurred at setup.There was no patient injury.

Event Description

See initial report.

Manufacturer Narrative

Venting valve was replaced two weeks before during pm.A device service history review has been performed and identified that the unit was manufactured in 2015 and no other similar event has been reported, neither concerning trend has been identified.Based on the information provided by field service technician, the most likely root cause of the reported issue is an adhesive failure of the recently replaced venting valve.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18002116
• MDR Text Key: 326452506
• Report Number: 9611109-2023-00565
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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