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

Model Number 16-02-80

Device Problem Temperature Problem (3022)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to a patient stirring mechanism or a pump during procedure.There was no patient injury.

Manufacturer Narrative

A1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) germany.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: the stirrer motor was blocked.In order to solve the issue, stirrer motor was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: a device service history review was conducted and identified that the involved unit was manufactured in 2019 and stirrer motor was already replaced during 2023 due to loud noise.In addition, no similar complaint concerning trend has been identified.Based on all the information collected, it cannot be excluded that the event occurred due to an early failure of the replaced component, since defective.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17488031
• MDR Text Key: 320795443
• Report Number: 9611109-2023-00385
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: 010403381790109911190902
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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