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

Model Number 10-80-00

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

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

Event Date 10/16/2023

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).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Functional verification testing was completed without issues and the unit was returned to service.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 gave an alarm related to cardioplegia and when the knob was adjusted to start the pump, the pump did not turn.There was a resistance in both directions, when the pump knob was manually turned.The issue occurred at setup.There was no patient injury.

Event Description

See initial report.

Manufacturer Narrative

A device service history review has been performed and identified that the unit was manufactured in 2007 and no other similar event has been reported, neither concerning trend has been identified.The reported symbol with a triangle and exclamation mark is displayed in yellow and indicates that the pressure value for warning/regulation has been reached and neither enrichment nor re-circulation has been activated.In regulation mode, when the pressure reached the regulation threshold, the pump speed is continually adjusted to the requirements of the perfusion in order to maintain the pressure constant and avoid reaching the stop limit.If a circle with the hearth is displayed in red with a lightning bolt, the cardioplegia controller has triggered a pressure alarm, a bubble alarm or a regulator stop, and the linked pump stops.The pump does not restart until the alarm situation is solved or the function overridden.Based on the fact that no issue could be reproduced, it cannot be ruled out that the pump was automatically adjusted and/or stopped by cardioplegia pressure controller due to reached set threshold and the roller pump over-occlusion due to a user error made the pump difficult to rotate manually.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 18138023
• MDR Text Key: 328120895
• Report Number: 9611109-2023-00604
• Device Sequence Number: 1
• Product Code: DWB
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 01/14/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2007
• 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