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

Model Number 10-80-00

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Livanova initiated an 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 was loosing power intermittently when moved during a procedure before entering bypass.There was no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.However, the cable was found twisted and kinked thus the power cord was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on findings, it cannot be ruled out that the reported event was due to an intermittent failure of the cable.Contribution of mechanical stresses and rough handling by the user cannot be excluded.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 12133606
• MDR Text Key: 265430529
• Report Number: 9611109-2021-00358
• 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: 07/08/2021

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: 10-80-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1