MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER COOLER 3T (208 VOLT)(FOR USA AND; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number	16-02-82
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that a 3t heater cooler, during a procedure, displayed an error associated with pump using too much power (ee6).Follow up clarified the involved circuit was the patient one.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.As per follow up, there was a leak of neraly 150 ml on the floor.The leakage was coming from the blind overflow blue tube that was not in its rightful position hence the cause on the overflow.However, the ee6 that was displayed was not the result of the overflow.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 part.
Additional Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue (ee6 in patient circuit).The circulatory motor was not working.The stirrer motor (contained in the patient bridge), the distribution board and the processor board were found to be faulty and were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Complaints database analysis revealed no similar event since unit installation in 2019.The most probable root cause of the reported event is a non-free to spin pump motor, likely due to environmental conditions, as water infiltration, humidity, condensation or high temperatures, that required a power overload to work, which could have resulted in an overcurrent ultimately caused damage to involved boards.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER COOLER 3T (208 VOLT)(FOR USA AND
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lilnderberstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17058351
• Report Number: 9611109-2023-00253
• Device Sequence Number: 6852566
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: (01)04033817900511(11)171025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown