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

Model Number 16-02-80

Device Problem Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2020

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).The technician in charge found out that the patient pump was blocked.The most likely root cause of the reported event can be traced back to a corroded and/or damaged motor ball bearing of the pump due to environment in which the pump works, such as condensation caused by water infiltration or high temperatures and high levels of humidity.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the patient pump during maintenance.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the reported event had been caused by the upgrade service activity.In this specific case, the failure would have been always detected prior to device use on a patient.Based on the above, the reported event is not likely to contribute to serious injury or death and has been reassessed as non reportable.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10545474
• MDR Text Key: 209381037
• Report Number: 9611109-2020-00528
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1