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

Model Number 16-02-85

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

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

Event Date 08/16/2023

Event Type  malfunction  

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 complained 3t heater cooler had previously a similar issue.The device was checked and no issue detected.The device was used again with no issue and then the problem reappeared.The device was checked again and found conforming.The heating and cooling of the system were tested per the service manual and no issue could be replicated.Customer was recommended to shorten the circuits since currently the used circuits are longer than recommended (ifu recommeds 16.4 feet while are 24-25 feet).The device was put back into use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, during a procedure, the 3t heater cooler failed to warm on the patient side.The water bath temperature was set to 41°c and after 15 minutes the water bath temp did not exceed 35°c.Medical team elected to change out the heater cooler and the same issue reoccurred (logged as additional livanova complaint, ref (b)(4)).Then replaced with a third heater cooler, the system worked properly and the procedure was completed with no issue.There is no report of any patient injury.

Manufacturer Narrative

No further intervention was deemed necessary; functional verification checks were performed and passed positively.The unit returned to service.A device service history review has been performed and identified that the unit was manufactured in 2016 and one other similar event have been reported one month previously for which the distribution board has been replaced.According to all the collected information, taking into consideration the insight reported by the livanova engineer through follow-up communication and the results of investigations conducted on previous similar instances of the failure, it cannot be ruled out that the most likely contributing factor to the event have been the length of the line was too long and/or the customer heated up both circuits at the same time.This report was due on november 30, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.

Event Description

See initial 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: 17744542
• MDR Text Key: 323397705
• Report Number: 9611109-2023-00435
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811161212
• 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: 01/10/2024

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: 08/16/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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