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 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The most likely root cause of the reported issue is the degradation of the cooling coil.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 tripped the fuse during use.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

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 was removed from service.The root cause is a hole of the evaporator due to stirrer flow in the tank and corrosive action of disinfectants.In this case, refrigerant will leak and water will enter the refrigeration cycle damaging the cooling compressor.Corrective action is already in place for this issue and implemented through installation of the erosion kit including new design of the pump head of the stirrer motor to prevent water flow directed to a narrow area of the evaporator coil.The issue was claimed more than one year after the upgrade after the upgrade, but most probably the condition of the evaporator was already compromised by degradation before device 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
• MDR Report Key: 12116462
• MDR Text Key: 261333117
• Report Number: 9611109-2021-00352
• 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
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1