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

Model Number 10-80-00

Device Problem Intermittent Continuity (1121)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2019

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 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 s5 roller pump is turning irregularly on low speed and was substituted by another pump during priming.There was no patient involvement.

Manufacturer Narrative

H10: a livanova field service representative has investigated the affected device.The service representative was not able to confirm the reported issue.Functional verification testing was completed without further issues and the unit was returned to service.As the issue could not be reproduced or confirmed, a root cause was not identified.

Event Description

See initial report.

• 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: 8763683
• MDR Text Key: 150162947
• Report Number: 9611109-2019-00518
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)160509
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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: 06/11/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1