MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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 01/13/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 mast roller pump stopped in operation giving an error message related to motor control.The pump started again immediately.The issue occurred during maintenance activities.There was no patient involvement.

Manufacturer Narrative

Livanova deutschland manufactures the s5 mast roller pump, the incident occurred in germany.Read out the pump send the manufacturer for verification.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

The pump involved was manufactured in 2020 and the review of the events on the serial number has highlighted no other complaints identified since its installation, therefore the case is isolated.No other additional information was provided on the event that occurred and no subsequent events were submitted by the customer on the impacted pump.There is no evidence of service intervention request confirmation by the customer.The presumed date of the event would be january 13, 2023, and the read-out analysis confirmed that no deviations/alarms/errors were stored on that date.Based on the findings mentioned above, an intrinsic failure of the electro-mechanical component can be excluded.Based on all facts above, the reported deviation only happened once and the root cause could be most likely related to a specific condition of custom pack setting inside the pump raceway / user technique or motor blocked by foreign object.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Manufacturer Narrative

The claimed error was displayed during a procedure (not during a maintenance) and not patient impact was reported.The complained error remains unknown (not found in the log file) and could not be reproduced.The complained pump was extensively tested by the livanova field service engineer and no issue could be found.Livanova field service engineer advised the customer to use the potential equalization cable.Based on the above, an intrinsic failure of the electro-mechanical component can be excluded.The reported deviation is isolated (happened once) and the most probable root cause was high frequency interferences from other device and/or a specific use condition and/or motor blocked by foreign object.Since the issue was not ascribable to any device malfunction, the event is being reassessed as not reportable.

Event Description

See intial report.

• Brand Name: MAST ROLLER PUMP 150
• 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: 16349693
• MDR Text Key: 309284943
• Report Number: 9611109-2023-00057
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)200630
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062396
• 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,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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