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 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Part replaced: 90-305-770.Controlador de motor hms 0409.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, during the procedure, the arterial s5 mast roller pump stopped.The control panel went black.The perfusionist started handcranking and he restarted the control panel.The screen worked again and returned an error on the s5 console, the pump didn't turn.The perfusionist switched the loop from the arterial pump to a backup pump.He reconfigured the alarms to the new pump.According to information , there was no impact on the patient.After the procedure, the perfusionist rebooted the pump, the arterial pump was working fine again.

Manufacturer Narrative

H.10: livanova field service technician was dispatched to customer facility and confirmed the reported issue.The motor control board was replaced, the unit was then tested and put back in service.According to complaints database analysis, no further complaint has been submitted for this unit since its installation in 2014.The root cause of the reported issue is traced back to a defective motor control board.

Event Description

See initial report.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15119636
• MDR Text Key: 298397243
• Report Number: 9611109-2022-00369
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K071318
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-95-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1