MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Insufficient Cooling (1130)

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

Event Date 10/21/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t was not cooling down on the patien side more then 25 degrees post procedure.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in usa.A livanova field service engineer reported also the customer complained of getting a press switch tripped (e27) and display button where not responding and needed to be replaced.The display keyboard, the processor board and patient circuit bridge were replaced.All components have been inspected and tested according unit returned to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2020.Based on the collected information, the root cause of the reported event of insufficient cooling can be traced back to a defective patient bridge.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event, however there is no concerning trend for this kind of failure.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• 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: 18148180
• MDR Text Key: 328269863
• Report Number: 9611109-2023-00609
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811201008
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• 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