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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue by applying automatic mode cardioplegia delivery.The failure could not be reproduced during manual mode application.A memory clear was performed on the roller pump and cardioplegia module.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 s5 roller pump rpm's dropped and pump stopped.The pump was used to deliver cardioplegia.There was no report of patient injury.

Manufacturer Narrative

H.10: in the automatic cardioplegia mode the pump rpm's dropped and the roller pump stops after the cardioplegia is delivered.This is the expected behavior of the pump once the cardioplegia solution has been administrated.Thus, no device malfunction was encountered.Considering the pump was tested and found to work properly, no hardware malfunctions that caused the failure can be identified.In addition, no further complaint regarding this issue on this specific unit has been received so far.Therefore, taking into account the available elements, it cannot be ruled out that the pump was running in automatic mode - although the user believed it was in manual mode - and stopped correctly after delivering the set cardioplegia dose.

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: 12180720
• MDR Text Key: 261935714
• Report Number: 9611109-2021-00376
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1