MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH 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 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.Confirmed fault - compressor shortage.Customer confirm that correct cleaning guidelines are followed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about a rcd trip as soon as the device is turned on.Confirmed fault - compressor shortage.Customer confirm correct cleaning guidelines are followed.No patient involvement reported.

Manufacturer Narrative

Manufacturing date of device has been added to the dedicated h.4 section.H.10: livanova field service representative dispatched to the facility confirmed the issue.He was able to traced back the fault in the damaged compressor of the cooling system.The unit will be removed from service.Complaints database analysis revealed no similar event since unit installation in 2013.Based on investigation 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 condition will cause immediate damage of the cooling compressor system.This is a known issue and corrective action is already in place.On 16-mar-2020 it was performed the erosion kit upgrade on the devices that 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 about more than 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.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 12376632
• MDR Text Key: 268445377
• Report Number: 9611109-2021-00478
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1