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

Model Number	HEATER/COOLER 3T 120V/60 HZ
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report about an heater-cooler 3t system showing the error code ee07, 'pump (stirring mechanism) is blocked (too slow)'.The issue occurred during procedure.There is no report of patient/user injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11 livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.The livanova's field representative confirmed the e07 error and found the distributor board ul 510 and the relative ribbon transmission cable to be causing the issue.These two defective components were replaced, and all technical and safety inspections were carried out and successfully passed.The unit was returned to the customer's facility.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Through follow-up communications, livanova learned the event was related only to device cardioplegia side.Based on the above, the event has been assessed as non-reportable, since it is not likely to cause or contribute to serious injury or death, even if reoccurred.Livanova will keep monitoring the market.

• Brand Name: HEATER-COOLER 3T SYSTEM
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24315326
• Report Number: 9611109-2026-90042
• Device Sequence Number: 5572915
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811180111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: HEATER/COOLER 3T 120V/60 HZ
• Device Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 01/11/2018
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown