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

Model Number 10-80-00

Device Problem Decreased Pump Speed (1500)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.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 the device and could not confirm the reported issue.The encoder and the processor board were replaced as precaution.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A video was shared with livanova.The results of the analysis will be provided in a supplemental report.

Event Description

Livanova received report that the rpms on a s5 roller pump dropped to zero twice during setup.There was no patient involvement.

Manufacturer Narrative

H.10: the most likely root cause is a temporary communication issue between the processor board and the shaft angle encoder.

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: 12281289
• MDR Text Key: 265182096
• Report Number: 9611109-2021-00417
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1