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

Model Number 16-02-82

Device Problem Insufficient Heating (1287)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-82 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).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a loose wire connection on the patient side.The connection was reseated and the problem solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t was not heating during setup.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: the root cause of claimed issue has been reasonably identified as misassembly error.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 11337570
• MDR Text Key: 258942480
• Report Number: 9611109-2021-00086
• 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: 02/17/2021

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: 16-02-82
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1