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

Model Number 10-80-00

Device Problems Failure to Sense (1559); Failure to Auto Stop (2938)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(4), japan.On-site checks were carried out on the device and the cause could not be identified.Livanova initiated an investigation.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 did not stop even when the pump cover was opened.The function was confirmed to be on.It was also confirmed that the other s5 roller pump stopped with the same settings.There was no patient injury.

Manufacturer Narrative

Through follow-up communication, it was learned that the field service engineer tested the functionality of the pump with a bubble sensor and the pump correctly stopped, therefore a mechanical/electrical failure of the pump could be excluded.The cover sensor (pn: 97-103-652) and the motor control board (pn: 90-305-770) were replaced.Reportedly, the board was functional but was replaced as a precautionary measure.A complaints database analysis was carried out and revealed that no further issues have been submitted for this unit since its installation in 2012.Based on the above facts, the root cause of the reported issue can be addressed as a defective cover sensor that has not triggered any alarm when the cover was opened so that the pump could stop.The pump stopped correctly at the bubble alarm so the problem was actually the cover sensor.The event shall be re-assessed as not reportable since cover sensor issue has unlikely possibility ot cause serious injury or death.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 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: 16033681
• MDR Text Key: 308546825
• Report Number: 9611109-2022-00686
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/24/2023

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: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2012
• 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