MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Ambient Temperature Problem (2878)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that, during a procedure, the 3t heater cooler displayed an error pump 1 is blocked (e07) on patient side.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-80 is not distributed in the usa, and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in usa.Livanova initiated an investigation if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Customer decided to order the stirrer motor and repair the equipment themselves.A device service history review has been performed and identified that the unit was manufactured in 2014 and one previous similar event has been reported in 2023.Based on all the above facts, it cannot be ruled out that the most likely root cause of the reported event is a jammed stirrer motor likely due to the wear of the component in contribution with the action of disinfectants during disinfection procedures and environmental condition in which the component was working, as high temperatures, humidity, and condensation.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 18777013
• MDR Text Key: 337419757
• Report Number: 9611109-2024-00097
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2014
• 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