MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problem Pumping Stopped (1503)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in china.From the analysis of the log file the errors have been confirmed on the dates of the events: (b)(6) 2023.An hms board defective is the most likely root cause of the event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that the single roller pump 150 displayed intermittently error "pump 1 motor controller error" and "pump 1 motor monitoring/controlling error" occurred respectively at 17:16 on (b)(6) and at 18:51 on (b)(6).There is no report of any patient injury.

Manufacturer Narrative

During the visit on site, the serial readout (real time device parameters and setting recording file) of the pump was collected.The analysis of the serial read-out revealed that the error code 458 (timeout_motor) was stored on the date of the events.Based on the investigation performed for similar cases, the stored error codes can be due to (i) disconnection of the motor from the motor control board and/or (ii) defective motor and stage board (hmf) and, in particular, to its dc/dc converter.Field service technician dispatched to the facility solved the issue by replacing the hms board.Complaints database analysis revealed no similar event since unit installation in 2021.Based on the error message displayed, the analysis of log and the service activity, the most likely root cause is an hms board defective.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.This report was due on november 30, 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 immediately following restoration of the livanova systems.

Event Description

See initial report.

• Brand Name: SRD S5 MAST ROLLER PUMP 150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17744189
• MDR Text Key: 323383415
• Report Number: 9611109-2023-00432
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)210623
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103762
• 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: 12/04/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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