MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); 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 10/26/2023

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 italy.A livanova filed service technician was dispatched on-site and confirmed the reported issue.The motor end-stage board and the motor control board were replaced.Mechanical /electrical checks and functional tests were carried out and passed successfully, therefore the unit was put back into regular service.A complaints database review revealed that no other issues have been submitted for the affected pump since its installation in 2008.The root cause of the reported issue has been traced back to faulty hmf and hms boards.The initial report was due on november 26, 2023.However, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.Meawhile, the investigation has been completed and included in the present report.

Event Description

Livanova deutschland has received a report that, during service, s5 roller pump 150 displayed motor control failure error (e435) several times.By turning the pump off and on again, pump started again and sometimes error returned.There was no patient involvement.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 18490854
• MDR Text Key: 332616995
• Report Number: 9611109-2024-00024
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1