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

Model Number 16-02-82

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Pumping Problem (3016)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed error on patient side during a procedure.There is no report of any patient injury.

Manufacturer Narrative

Follow up with the customer confirmed the error could not be remembered.A livanova field service engineer was dispatched to the customer site and the claimed error on patient tank display was not reproducible.The unit was found empty and refilled and then it was observed a leak from patient circuit tubing.Finally visual inspection and functional safety checks were successfully completed per guidelines and unit returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER COOLER 3T (208 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: 17921219
• MDR Text Key: 326196898
• Report Number: 9611109-2023-00518
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1