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

Model Number 16-02-80

Device Problems Temperature Problem (3022); Unexpected Shutdown (4019)

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

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) 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

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message during procedure and burning smell came out of he device.The affected circuit (patient side/cardioplegia side) is unknown.A malfunction of the stirrer motor on the patient side cannot be excluded.There was no report of patient injury.

Manufacturer Narrative

H.10: through follow-up communication livanova learned of a device breakdown due to defective compressor.This issue is different from the one reported initially.Clarification regarding the issue affecting the device is pending to livanova.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

Livanova deutschland received a report of a heater-cooler system 3t shutdown during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: device breakdown due to defective compressor is a known issue.Based on findings, a potential breach of the cooling coil can be generated due to stirrer flow in the tank.Consequently, the water will enter the cooling circuit and the compressor unit.This will cause damages to the cooling compressor.Corrective action is already in place for this issue.The erosion kit upgrade was performed on 23-sep-2020 on the device and includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue was claimed less than one year after the upgrade, but most probably the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.There is no confirmation of the error code associated to the stirrer motor thus, b.5 section and codes associated to device problem in h.6 section have been updated accordingly to the device shutdown.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for evaluation.The complete cooling system needs to be replaced.The customer decided to not repair device.

Event Description

See previous follow up 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12306145
• MDR Text Key: 265979328
• Report Number: 9611109-2021-00430
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1