MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Catalog Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump 150 displayed error "maximum load limit was reached" durign set up.There was no patient involvement.During follow up with the customer it was clarified the pump stopped with an error message of ¿maximum load limit was reached (672) pump 1".

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in united states.According to the perfusionist the occlusion had been reset and they were still getting this error both using livanova or other vendor tubing sets.A livanova field service engineer was dispatched to the customer site and motor control boards behaved as expected: the runaway pump and direction of rotation error appeared as expected.Pump raceway were found for out of round.No deep scoring on the raceway.Some of the finish in the raceway is wearing off: difference in the sheen of the finish where the tubing rides, as well as a very fine/soft powdery substance in the bottom of the raceway was visible.Powdery substance in the bottom of some of the other raceways was also visible.Possibly this to be wear on the raceway overtime.Customer decided to not change the pump.Livanova recommended to use the pump as a sucker or a spare pump.Unit returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

A device service history review has been performed and identified that the unit was manufactured in 2008 and no other similar event has been reported.Based on the technical intervention, it cannot be ruled out that the most likely root cause of complained event was a combination between high speed set and the presence of the fine powdery not properly cleaned by user that may have temporary affected the electronics but was definitively fixed by service technician throughout the equipment check.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17963301
• MDR Text Key: 326015839
• Report Number: 9611109-2023-00537
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2008
• 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