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

Catalog Number 10-80-00Z

Device Problems Failure to Pump (1502); Failure to Auto Stop (2938)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service engineer was dispatched to the customer.The pump was internally inspected and no abnormalities found.The pump was extensively tested and no faults could be reproduced.All software confirmed at correct revision and functional checks carried out satisfactorily.The customer has relocated the complained pump that will be sent to manufacturer for further investigation and repair.Read out were inspected and no error was stored in the pump's read-out.So far, the customer has not reported observing this on any other roller pump.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received report that the arterial pump experienced a pump creep.In details, when the flow was stopped using the speed control knob, it would stop but then, after a couple of seconds, the flow would start back up at a very low flow rate (0.1-0.3lpm).This happened repeatedly during a case (with no negative effect).The pump was taken out of service.There was no patient injury.

Manufacturer Narrative

The pump was sent to the manufacturing site for further investigation and no hardware malfunctions were detected during the functional testing activity.The pump worked fine for a week with no issues with and without tubing.The pump involved was manufactured in 2021, and the review of the complaints showed that no other similar events have been recorded.However, two other similar complaints registered by different customers have been identified.Based on all available information and investigation of previous similar events, the most probable root cause is that the rpms of the pump were not actually set to zero when the pump creep was detected by the user.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15814623
• MDR Text Key: 307667424
• Report Number: 9611109-2022-00594
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: 010403381790271311211018
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-80-00Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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