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

Model Number 16-02-80

Device Problem Electrical Shorting (2926)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).Livanova through follow-up communication with the customer, learn that additional sockets has been tested including sockets with test and reset functions and all of them caused the tripping of the mains circuit of the hospital.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The unit would power up as usual and when the temperature was lowered it would trip the power.The failure was traced back to a short circuit of the cooling compressor due to loss of refrigerant gas.The unit was removed from service and will be scrapped.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t device tripped the mains circuit of the hospital during disinfection and cleaning processes.There was no patient involvement.

Manufacturer Narrative

The reported event is a known issue: breach of the cooling coil can be generated due to stirrer flow in the tank.Consequently, the water will enter the cooling circuit and the compressor unit.This potential failure mode will cause immediate damage of the cooling compressor system.The compressor failure leads to an increase of the leakage current of the device and the circuit breaker will trip.Complaints database analysis revealed no similar case notified since unit installation in 2017.Sap analysis revealed that on august 22nd, 2019 it was performed the erosion kit upgrade of the devices that includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue was claimed about more than three years after the upgrade, and, most probably, the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.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 SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80004 ; GM 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15994376
• MDR Text Key: 305843219
• Report Number: 9611109-2022-00679
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: (01)04033817901099(11)170320
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 03/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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