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

Model Number 16-02-80

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

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that, then the heater-cooler system 3t has been turned on, there was a massive leak of water from the area above all 4 wheels.Additionally, water runs out of the ventilation.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.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 germany.Cardioplegia block leaking water, patient pump 1 makes loud whining noises, bearing damage.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

The unit was beyond repairable, no repair activity was performed and the unit was put out of service.Analysis of complaints database resulted in no further similar leakage instances notified for this device since installation in 2017.Based on all the above facts, taking into account the evidences collected by technician and considering the manufacturing year of the device, it cannot be excluded that the most likely root cause of the reported event is related to the wear/material degradation of the unit due to wearing.The wearing of electro-mechanical devices can be originated by the specific use condition at customer site that may have contributed to the event, such as movements or liquids penetration.However, there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: 3T HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18281081
• MDR Text Key: 329895911
• Report Number: 9611109-2023-00622
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/11/2024

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: 16-02-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2017
• 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