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

Catalog Number 28-95-80

Device Problem Pumping Stopped (1503)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Livanova deutschland manufactures the s5 roller pump.The incident occurred in hamburg, germany.After a pressure stop, the pump did not restar.The mast roller pump mrp 150 was checked.Pump is unusually noisy.The pump will be sent to repair.Readout created and no errors were stored on 17 oct 2022 into read-out.Livanova initiated an investigation.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 mast roller pump stopped after a pressure alarm (at 650 mmhg) and did not restart.Customer wants the pump to be checked.There was no patient injury.

Manufacturer Narrative

H10: through follow-up communication livanova learned that the pump was unusually noisy during operation; after resolving the pressure alarm, the arterial pump has never re-started.The user turned off and on again the pump and no issue was fixed.Then the hand-cranking of the pump was started from the user.The serial read-out of the pump (real time device parameters and setting recording file) was analyzed and it cannot be ruled out that the event occurred on 11 october 2022, indeed, the pressure alarms were stored in that day as well as error code related to pump rotation manually (hand-crank).The unit returned to manufacturing's site and during inspection no error message could be traced and reproduced.Pump noise at high speed range was due to damaged bearings.In order to fix this issue bearing ring was replaced.Subsequent functional verification testing was completed without further 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

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2012.Based on the information collected and on the manufacturing date of the pump (2012), a stiffness of the pump head which made the rotation of the pump inefficient due to bearing damage cannot be excluded as root cause of the reported event.Consequently, following the restoring of the pressure alarm, the pump no longer restarted.

• Brand Name: S5 MAST ROLLER PUMP
• 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: 15814592
• MDR Text Key: 305505707
• Report Number: 9611109-2022-00593
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/15/2022

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: 28-95-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• 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