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

Model Number 16-02-80

Device Problem Device Alarm System (1012)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report of a heater-cooler system 3t showing several error messages after a procedure.No further detail is available.A malfunction of the patient circuit cannot be excluded.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.4.Manufacturing date of device was incorrectly reported in the initial report.The correct date has been updated in the dedicated h.4 section.H.10: no information about the error codes was received from the customer, however through follow-up communication livanova learned that the device is used in the research department of the hospital and that it is not dedicated to be used on patients.Indeed, this unit is not subjected to regular preventive maintenance since 2014.The device will no longer be used or repaired due to its very old age.Reportability decision changes to not reportable event based on the fact that no serious injury occurred, the machine was not dedicated to clinical use and therefore not subjected to regular maintenance as prescribed by instruction for use since 2014.Thus, for this specific device, the reported event cannot result in serious injury even if recurs.

• 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; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13235142
• MDR Text Key: 283959680
• Report Number: 9611109-2022-00023
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 01/12/2022

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: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2000
• 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