MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.Upon inspection, he found out that the internal of the pump, including the cooling fan, was full of lint leading the pump to overheat.The motor controller board and end stage board were replaced and the lint was cleaned.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The affected parts were requested back to livanova (b)(4) for a detailed investigation.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 s5 roller pump stopped and an error message was displayed.This issue was identified by a livanova field service representative during maintenance.There was no patient involvement.

Manufacturer Narrative

H.10: investigation results on the replaced components could not confirm the reported malfunction.During visual inspection and functional tests no deviations could be identified.It is very likely that an inadequate cleaning led to the reported event.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.

Event Description

See initial.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8523469
• MDR Text Key: 147332688
• Report Number: 9611109-2019-00267
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• 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: 07/25/2019

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: 10-80-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1