MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

There was not patient involvement.Livanova deutschland manufactures the s5 double roller pump 85.The incident occurred in italy.The read-out of the pump was executed.Boards hmf (motor end stage board) and hms (motor control board) have been replaced.Functional test performed and unit returned to customer 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 double head pump showed fault in motor controller error (e429) during priming for pump head b.There was no patient involvement.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2015.It cannot be excluded that an electrical/electronic deviation of the replaced components (boards) was the root cause of the reported issue.

Event Description

See initial report.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• 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: 16204963
• MDR Text Key: 308234923
• Report Number: 9611109-2023-00030
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)170725
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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