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

Model Number 16-02-80

Device Problem Insufficient Heating (1287)

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

Event Date 02/23/2021

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 hanoi, (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The internal tubings of patient circuit were found to be torned and the device could not suck the water back from the external tubings to the tanks completely.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 having heating issues on the patient side during procedure.Reportedly, the temperature could not increase.The device was replaced with another to continue the procedure.There was no report of patient injury.

Manufacturer Narrative

H10: poor flow of water to the blanket and the oxygenator led to the reported issue.After replacing and tightening tubes, the flow improved and the problem could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 11555012
• MDR Text Key: 280202859
• Report Number: 9611109-2021-00146
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 10