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

Model Number 16-02-80

Device Problem Electrical Shorting (2926)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t tripped the rcd (residual current device) of the hospital during cooling on procedure.There was no patient injury.

Manufacturer Narrative

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).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in randwick, australia.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.An electrical safety test was carried out: ground resistance reading over limits and kept tripping rcd (residual current device) of the hospital.Air bubbles were noticed in the patient tank, suggesting a damage in the cooling coil.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: complaints database analysis revealed that no similar event on this device occurred since its installation in 2017.The reported event is a known issue.Livanova put in place corrective action to reduce this type of events in case of breach of the cooling coil being generated due to stirrer flow in the tank leading to hole formation in a narrow area of the coil.However, in this specific case, the exact location of the hole on the cooling coil could not be determined.Consequently, the water will enter the cooling circuit and the compressor unit.This potential failure mode will cause immediate damage to the cooling compressor system.The compressor failure leads to an increase in the leakage current of the device and the circuit breaker will trip.In june 2020 it was performed the erosion kit upgrade of the device that includes the new design of the pump head of the stirrer motor to prevent the water flow directed to the narrow area of the cooling coil.The reported event was claimed after the upgrade and it is not possible to exclude that the condition of the cooling coil was already compromised before the upgrade to such an extent that the copper was rather degraded.

• 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: 15864222
• MDR Text Key: 305699886
• Report Number: 9611109-2022-00611
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: (01)04033817901099(11)170816
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• 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: 02/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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