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

Model Number 10-80-00

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The affected pump was requested back to the manufacturer site for investigation.Results confirmed the reported issue which was traced back to a defective pump head resolver.The part will be replaced in order to solve the reported problem.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 was giving a motor control failure error message at the power up.The error persisted later on.There was no patient involvement.

Manufacturer Narrative

The pump head was replaced and the issue was solved.As per equipment maintenance interventions prevention also other parts were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

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: 10520085
• MDR Text Key: 209382790
• Report Number: 9611109-2020-00515
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1