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

Model Number 16-02-82

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 03/06/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 312589895
• Report Number: 9611109-2023-00136
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: 010403381790051111171025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2017
• 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