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 07/28/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that, during re-warming, even though the temperature was set to 41°c in the 3t heater cooler, the water wouldn¿t warm up more than 33.5°c.Medical team elected to replace the heater cooler with another one.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 united states.The livanova field service representative in charge went on site, ran system and temperature would reach desired value in time specification of what is expected in the manual.To solve the issue, the ring core transformer and the distribution board were substituted.After that, the system was tested again and found again in specifications slightly faster.Throughout follow up with the customer, the 3t heater cooler patient side was affected.Attempt to clarify if long line or line left on the floor have contributed were not successful.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 2016 and no other similar events have been reported.The most likely contributing factor to the event have been the length of the lines (too long) and/or the customer heated up both circuits (patient and cardioplegia) at the same time.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: 17649180
• MDR Text Key: 322254798
• Report Number: 9611109-2023-00404
• 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
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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: 07/31/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/16/2023
• 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
• Patient Sequence Number: 1