MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problems Failure to Pump (1502); Temperature Problem (3022)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t, when turned on, displayed an error code associated to patient circuit 2 pump that did not start (power consumption is too low).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 jackson, michigan.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Through follow-up communication, livanova learned that the error messages occurred after the patient pump 2 replacement following a noise problem.Field service technician was dispatched to the facility and found the replaced patient pump defective.To solve the issue a second new pump has been installed.All functional tests positively passed and the unit was put back into service.Complaints database analysis revealed no similar out of box event over the last 3 years.Based on the above, the root cause of the event was an isolated manufacturing failure of the new patient pump: out of box failure.The issue would in any case be detected during installation and therefore is always detectable before use.The event has been reassessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17610054
• MDR Text Key: 321807286
• Report Number: 9611109-2023-00394
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)161115
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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