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

Model Number 48-50-00

Device Problem Failure to Auto Stop (2938)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 system.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.The failure is intermittent.A video of the failure was provided and analysis revealed that despite rotating the knob to zero rpm, the indication of the rpms displayed on roller pump is not zero.The serial read-out of the pump has 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.

Event Description

Livanova (b)(4) received a report that a more than one pump used on a s5 system have a tendency to pump creep.Reportedly, the pumps correctly stop when the speed control knob is set to sero rpm but they start to turn again spontaneously.If the pump is stopped through the push button on the touchscreen, the reported issue doesn't occur.There was no report of patient injury.

Manufacturer Narrative

H.10: read-out analysis did not reveal deviations.No hardware / software issues have been stored during the day of the fse visit on site, during which the issue could be reproduced.Currently the customer is likely using the pumps stopping them by pressing the stop function button on the touchscreen.Investigation still on going.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: affected roller pumps have been removed from service and loaners device have been provided to the customer.Through follow-up communication, livanova learned that the reported issue could be reproduced in approximately 1 out of 10 attempts.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: the most likely root cause of the reported event is to be traced back to a malfunction of the shaft angle encoder.In detail, to the variability of the involved components with respect to the clinical use (the issue is reproducible only when rapidly turning the speed knob to zero).The shaft angle encoders were replaced by the technical department before shipping the roller pumps back to the customer.

Event Description

See initial report.

Manufacturer Narrative

H.10: two roller pumps affected (serial numbers: (b)(6) were returned back to livanova for product analysis.Investigation confirmed the reported issue.When turning rapidly the speed control knob, it can occur that, despite the bip sound, the rpm displayed is 1 (and not zero) and the pump runs accordingly.When the knob is turned very slowly and rpm are set to 0, the bip sound is not present and the rpm rapidly became 1 (and the pump runs accordingly).There are no errors stored in the pumps read-out.The same behavior was reproduced on both the roller pumps.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: S5 SYSTEM
• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13023921
• MDR Text Key: 282385970
• Report Number: 9611109-2021-00710
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: 010403381790090011200907
• 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,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-50-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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