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

Model Number 16-02-82

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 issue.The technician stated that there was a power surge and it shorted out the power supply.The power supply board was replaced and a new two pins plug was installed.The issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 that a heater-cooler system 3t was not turning on during setup.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: a visual inspection of the affected part was performed and revealed burn marks on a connector and terminals.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 9087232
• MDR Text Key: 178158772
• Report Number: 9611109-2019-00737
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1