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

Model Number 16-02-80

Device Problem Insufficient Cooling (1130)

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

Event Date 07/23/2021

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).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The device was inspected and bubbles from the cooling coil were detected indicating a refrigerant leak.Unit was taken out of service and new loan provided.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 device was not cooling efficiently after a procedure taking too long to cool down.There was no report of patient injury.

Manufacturer Narrative

H.10: the most likely root cause of the reported event is degradation of the cooling coil leading to an hole causing refrigerant leak and water entering refrigeration cycle which damaged the compressor.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the reported issue may have been due to the use of disinfectant.Further communications with the customer site is ongoing in order to clarify the cause of the cooling coil degradation and the device has been requested for investigation.

Event Description

See initial report.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for investigation.Preliminary analysis reveals that the degradation of the cooling coil in not related to the stirrer flow generated by the stirrer motor in the patient tank.Indeed, the device is upgraded with the erosion kit which includes a new design of the stirrer motor head preventing water flow to be directed to a narrow area of the evaporator coil.Investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: further analysis of the device reveals no bubbles were observed on the patient tank cooling coil and cardioplegia tank.However the device reached the set temperatures exceeding the time prescribed by manufacturer specifications.The presence of micro-holes and a leak from the cooling coil cannot be excluded at the moment and additional intensive investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: a deep inspection at manufacturer site was performed and the results highlighted that the degradation of the coils led to the thinning of the copper in a zone that created a micro-hole, not visible to the naked eye.Therefore, due to the loss of refrigerant the device was malfunctioning during cooling.Based on all facts mentioned above, the root cause of the reported issue was traced back to a refrigerant leak from the cooling system due to micro-holes on the cooling coil.

Event Description

See initial report.

Manufacturer Narrative

H.10: the device has been scrapped.

Event Description

See initial 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: 12318510
• MDR Text Key: 266402177
• Report Number: 9611109-2021-00455
• Device Sequence Number: 1
• Product Code: DWC
• 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,Followup,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 04/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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