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 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learned that even if involved pump stopped, it continued to run and no alarm appeared.As per settings set, cardioplegia pump stop was linked to arterial pump.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.All functional verifications was successfully performed.The unit was updated to the latest firmware and it returned to service.The serial read-out of the involved stopped pump (real time device parameters and setting recording file) was analyzed: no pump malfunction occurred on the date of the event.On (b)(6) 2023 the pump stopped due to the stoplink function (master_stop) and due to the end of delivery of set amount of cardioplegia (encoder_stop).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 roller pump, used as cardioplegia, stopped during procedure.However, pump display showed a flow anyway.The user used a back-up pump in order to complete the surgery.There was no patient injury.

Manufacturer Narrative

According to the complaints' database, no other similar issues have been submitted for this unit since its installation in 2017.Based on the above facts, a hardware malfunction of the claimed unit can be ruled out and the most likely root cause of the discrepancy between the actual flow and the value showed on the display can be traced back to a temporary internal temporary electrical failure.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: 17124974
• MDR Text Key: 317594079
• Report Number: 9611109-2023-00265
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)170720
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• 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