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

Model Number 16-02-80

Device Problem Pumping Problem (3016)

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

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and 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).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device repaired by technical service provider.

Event Description

Livanova received report that in march or april 2020 a heater-cooler 3t was down with a patient pump faulty.The device was reportedly last used on (b)(6) 2020 thus it is likely that the fault occurred in march 2020.The device was repaired by a technical service provider in june 2020.No additional information is currently available and a reportable malfunction cannot be excluded.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow up communication livanova learned that an error code associated to patient pump was displayed on the patient side and another error code was displayed on the cardioplegia side of the heater cooler 3t system.The failure was traced back to faulty patient pump 1 and cold cardioplegia pump that were replaced in order to fix the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The issue is more likely associated to the motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate; possible causes could be water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14615855
• MDR Text Key: 293458128
• Report Number: 9611109-2022-00290
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/06/2022

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: 05/09/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2014
• 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