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

Model Number 10-80-00Z

Device Problem Pumping Stopped (1503)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump pro.The incident occurred in san antonio, texas.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix it, motor control board and front panel of the s5 roller pump pro were replaced.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 roller pump pro gave two motor control failure error messages at setup.There was no patient involvement.

Manufacturer Narrative

H10: the involved pump is installed since 2021 and according to the review of the complaints database, no further event has been reported for this unit.Based on the information available, it cannot be excluded that the root cause could be traced back to an electrical/electronic deviation involving the replaced parts.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP PRO
• 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: 16551468
• MDR Text Key: 311657347
• Report Number: 9611109-2023-00108
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)210930
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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