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

Model Number 16-02-85

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

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that, during priming, leak was indentified under the 3t heater cooler.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.A field service engeneer was dispatched to the customer site and found the complained 3t heater cooler was removed from service.Observed evidence of a leak from under the tanks.After an inspection, found the plastic "t" fitting cracked and leaking.Replaced the hoses and t fitting.Returned unit to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: according to the complaints database review no other similar issue have been submitted for this unit.Based on the information collected, it cannot be ruled out that the root cause of the observed leak was related to a degradation of the external tubing t-connector which no longer allowed the seal, due to wear.

Event Description

See initial report.

• 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: 18639261
• MDR Text Key: 334529641
• Report Number: 9611109-2024-00061
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)211028
• 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: 04/23/2024

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
• 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
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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