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

Model Number 16-02-85

Device Problem Temperature Problem (3022)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a 3t heater cooler presented an e06 on the cardioplegia side during a procedure.There is no report of any patient injury.A livanova field service engineer was dispatched to the customer.During inspection it was verified the motor wouldn¿t spin because it was rusted under the motor and the bearings seized.

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states field service was dispatched and the stirrer motor, cp bridge and distribution board were replaced system function normal 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: during field service engineer activity, also cardioplegia pumps were replaced.Based on investigation results of similar complaints and taking into account the manufacturing date of the unit (2016), it cannot be ruled out that the most likely root cause of the reported event has to be traced back to motor bearing damaged by the corrosion both for circulator motor and cardioplegia pumps, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.Causes related to environmental conditions.This lead the unit to request for an electrical power overload, which could have resulted in an over current that ultimately could have damaged the distribution board.

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; 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: 16204959
• MDR Text Key: 309018661
• Report Number: 9611109-2023-00031
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811161108
• 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: 01/19/2023

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: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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