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

Catalog Number 10-80-00

Device Problem Failure to Auto Stop (2938)

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

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that, during priming a s5 roller pump, even if stopped by the user, it started again in the opposite direction for a while and then stopped.It was an intermittent failure; it happened three (3) times.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in france.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: the unit was sent to the manufacturing site for further investigation.The reported issue was confirmed and the motor control board (hms) was replaced to solve it.Subsequent functional verification testing was completed without further problems and the unit was returned to service.The hall sensors of the pump motor, which detects the position of the rotor's rotating magnetic field, are connected to the board involved via a socket.Consequently, based on technical intervention reported above, it cannot be ruled out that this hms board failed and did not allow for correct signal processing.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event.The pump involved was manufactured in 2015 and the review of complaints revealed no other similar occurrences involving this unit.Thus, the event is an isolated case.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17117862
• MDR Text Key: 317059775
• Report Number: 9611109-2023-00259
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: 010403381790038211151013
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210130
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-80-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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