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

Model Number 16-02-80

Device Problem Insufficient Heating (1287)

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

Event Date 08/02/2021

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 not heating to the set temperature on the patient side during procedure.Reportedly the cooling started with no input from the user.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: no service activity has been scheduled yet on the device.Based on the available information, it cannot be ruled out that the water in the patient tank was not warming up enough and the water in the two cardioplegia tanks was not cooling enough.It is not possible to exclude that the two issues were related to a common root cause.The malfunction could be due to several factors: (i) a defect in the processor board to which the temperature sensors are connected which could drift and not read the correct value reached; (ii) a defect in the cooling system valves which may not properly control the amount of refrigerant entering the evaporator.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: a video of the reported failure was provided to livanova.The reported condition could be confirmed by analysis of the video.It was was also identified that the reported warming issue on the patient side was present only when cardioplegia circuit is activated at the same time.If cardioplegia circuit is not activated, the heating on the patient side works.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

Udi code has been added to the dedicated d.4 section and manufacturing date of device has been corrected.H.10: the affected device was returned at the manufacturer site for evaluation.Results revealed that the complete cooling system needs to be re-assembled.Thus, the root cause of the event can be traced back to a defective cooling system.The repair of the unit is on hold since the customer decision on device repair is still 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

See initial report.

Manufacturer Narrative

H.10: a deeper investigation has been performed on the cooling system and revealed that degradation of the coils led to the thinning of the copper creating a micro-hole.Therefore, due to the loss of refrigerant the device was malfunctioning during cooling.Thus, the root cause of the reported issue was traced back to a refrigerant leak from the cooling coil due to degradation resulting in a micro-hole.The device will be scrapped under customer decision and a replacement device will be provided.

• 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: 12390625
• MDR Text Key: 268912714
• Report Number: 9611109-2021-00481
• 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,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2019
• 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