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 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learned that the most likely the perfusionist switched on the pump while hand-cranking and this was the reason of the error message appeared after restarting the pump the first time.In addition, livanova learned that the hospital doesn¿t use a bubble detector.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 suddenly stopped just before weaning at the end of the procedure and alarm was displayed.The pump was tuned off and back on and another error message appeared.The user wanted to start hand-cranking but air was noticed in the arterial line.The arterial line was clamped and disconnected, the circuit was de-aired by hand-cranking and then re-connected to the cannula.The pump was restarted for the second time and no further issues occurred.Reportedly, there was no blood flow to the patient for 3,5 minutes.The procedure could be completed successfully.There was no report of patient injury.

Manufacturer Narrative

H10: the affected device was requested back to the manufacturer site for investigation.The pump serial read-out was analyzed and results confirmed that at the time of the event the user performed the hand crank.Furthermore, an error message indicating a can interruption was stored indicating a communication interruption between the s5 ep-pack and the roller pump.A functional test was performed on the returned roller pump.The unit was tested for 6 hours and no deviations occurred.The reported issue could not be reproduced.Since the issue could not be reproduced during the check on site and during investigation, the most likely root cause of the event was traced back to a failure of the cpu board of the roller pump, on which the can connector is located.

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: 11855079
• MDR Text Key: 252605399
• Report Number: 9611109-2021-00284
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1