MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (230 VOLT); 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 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in turkey.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, during a procedure, a heater-cooler system 3t displayed an error message (error 6) associated pump is using too much power.There is no report of any patient injury.The 3t heater cooler was inspected and it was found the distributor board and stirrer motor need to be replaced.

Event Description

See initial report.

Manufacturer Narrative

H10: complaints database analysis revealed no similar event since unit installation in 2022.Based on the information collected, it cannot be excluded that because of rusted/corroded/damaged motor bearings, likely due to environmental conditions, as water infiltration, humidity, condensation or high temperatures, the motor was no longer rotating freely and required a power overload to work, which could have led to an over-current that ultimately caused damages to the distribution board.

• Brand Name: HEATER COOLER 3T (230 VOLT)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18355019
• MDR Text Key: 330876649
• Report Number: 9611109-2023-00643
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: (01)04033817901099(11)220221
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 02/29/2024

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: 16-02-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1