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 Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report of water leaking from a 3t heater cooler during a procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
Patient information was not provided.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that the water leak was internal to the device.Indeed, a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: water was leaking from the t-connection on the internal blue tubing.In oder to solve the issue, blue tubing set was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Therefore, being the water leak internal to the device, it is unlikely to cause serious injury to the user.Thus, the event has been re-assessed as not reportable.

• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16663445
• Report Number: 9611109-2023-00136
• Device Sequence Number: 20314363
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: 010403381790051111171025
• 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): 03/06/2023

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
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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