MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Insufficient Heating (1287)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that, during a procedure when trying to warm the patient, the procedure was delayed because the heater-cooler system 3t was no warming above 37.3°c despite being set at 40.9°c.The lines were separated between patient and cardiolegia circuits, lines were long.Medical team elected to change the heater-cooler system 3t and procedure was completed with no issue.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in usa.The livanova field service representative in charge tested and system would warm with test loops properly.Mains ac board and ring core replaced as safety measure.After replacement it was confirmed that the device was still heating properly and it was a little slow when using hospital longer lines.Longer lines can affect heating performance.Moreover, as per paragraph 5.6.3 of ifu leaving the cardioplegia circuit active reduces the patient circuits¿ heating/cooling performance.It cannot be excluded that they were trying to warm both lines and the patient side was slowed down by the cardioplegia side.No device malfunction confirmed, hc3t is working properly.It cannot be confirmed or excluded the event was only related to customer error if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

A device service history review has been performed and identified that the unit was manufactured in 2018 and further previous similar events have been reported.The most likely root causes of the reported event can be assigned to one or more of the following: - hospital longer lines: longer lines can affect heating performance by circulating more water out of the device at room temperature, therefore dissipating heat.- heating of cardioplegia and patient lines at the same time: as per paragraph 5.6.3 of ifu leaving the cardioplegia circuit active reduces the patient circuits¿ heating/cooling performance.- temporary electrical failure of one or more of the replaced components; failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, and power overloads/surges but also to variability of micro sub-components.However, there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18747436
• MDR Text Key: 336880942
• Report Number: 9611109-2024-00089
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811180302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2018
• 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
• Patient Age: 62 YR
• Patient Sex: Male