MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that dual rollerhead pump failure during cardioplegia administration.After cross clamp was placed, cardioplegia pump was turned on to administer arrestingc ardioplegia dose.A clamp was left on cardioplegia line at the field, so high line pressure alarm was triggered on the cardioplegia pump.Clamp at field was opened and high pressure was relieved.When trying to resume arresting cardioplegia dose, the cardioplegia pump failed to move/run.Perfusion cleared the high-pressure alarm and ensured that pump was in the correct delivery mode and even tried to deliver in a recirculation mode.When trying to turn the pump on again, rpm¿s and flows were being shown without the rollerhead moving.To arrest the heart, the perfusionist had to remove the tubing from the pump head and hand squeeze cardioplegia to the field for the surgeon to deliver by syringe.Once heart was arrested, cardioplegia pump was turned off and back on and resumed working.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 double roller pump.The incident occurred in united states.A livanova field service engineer was dispatched to the customer site.Evaluation and functional checks were performed and no issue could be reproduced.Unit is functional and ready to use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

Manufacturer Narrative

H10: the serial read-out of the pump (real time device parameters and setting recording file) was analyzed: no technical error was found on the date of the event excluding a hardware malfunction.Based on technical intervention carried out and considering the serial read-out analysis, it cannot be ruled out that the inability to restart the pump could be caused by any monitoring function activated during the procedure with still alarm condition on (e.G.Pressure alarm).

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• 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: 17921236
• MDR Text Key: 326375924
• Report Number: 9611109-2023-00519
• Device Sequence Number: 1
• Product Code: DWB
• 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: 02/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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