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

Model Number 28-95-85

Device Problem Failure to Auto Stop (2938)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Livanova received report that a s5 mast roller pump did not stop when the arterial pump stopped despite stop link function being activated between the two pump.The issue occurred during priming.Reportedly, when the arterial pump stopped the slave pump continued to turn resulting in de-priming of the oxygenator.The pump controller was switched off and once turned on again it worked fine.The device was taken out of service.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in london, united kingdom.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The device worked within specification and stop link function was confirmed to be normal.Serial read-out of the pump have been taken and will be analyzed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: through pump serial read-outs analysis it was confirmed that arterial pump stopped twice while the other pump continued to run, confirming the complaint description.The processor board of the follower pump was replaced as precautionary measure.User settings reinstalled, software checked and control panel connection to e/p pack moved to another socket after contact cleaner application to plug pins.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

See initial report.

Manufacturer Narrative

Based on collected information, the most likely root cause of the reported event is a temporary electronic failure of the processor board of the follower pump.

Event Description

See initial report.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15281404
• MDR Text Key: 298490254
• Report Number: 9611109-2022-00425
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

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: 28-95-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/22/2022
• Supplement Dates FDA Received: 09/21/2022; 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1