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

Model Number 10-80-00

Device Problem Failure to Auto Stop (2938)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The motor control board was replaced as precautionary measure.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The customer decided to use the pump as sucker instead of arterial position.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a s5 roller pump kept rolling despite rpm set to zero and rotated backwards before a procedure.This incident happening between 13:30 and 13:35.The issue was not reproduced afterwards and the pump was used for the procedure.There was no patient injury.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2007.Based on the investigation results for similar cases, the reported event can occur if the occlusion is wrongly set and the tube is not correctly positioned inside the pump head.In this case, if the pump is stopped by knob and not by the alarm, the pump can still works (minimum rolling) since it is under electrical current.This, in association with the possible resistance of the tube and the adjustment of the occlusion not adequate could have led to the reported event.For this reason and considering that no hardware malfunction has been found by livanova technician, it cannot be ruled out that most likely root cause was due to occlusion adjustment and/or tubing positioning not properly set.

Event Description

See initial report.

• Brand Name: S5 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15508771
• MDR Text Key: 301269955
• Report Number: 9611109-2022-00491
• Device Sequence Number: 1
• Product Code: DWB
• 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: 09/26/2022

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: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2008
• 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