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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learned that the fault could not be reproduced.The investigation is ongoing.

Event Description

Livanova (b)(4) received a report that a s5 roller pump stopped at the end of the procedure.There was no report of patient injury.

Manufacturer Narrative

H10: the field service technician in charge for this center did not reproduce the reported fault during the on site service activity.The serial read out (real time device parameters and setting recording file) of the affected pump was not provided.However, through follow up communication, livanova learned that a similar event occurred with another pump connected to the same ep-pack can connector (the event was reported to fda under mfr report number 9611109-2021-00238).Thus, the serial read-out of the pump involved in the event 9611109-2021-00238 was analyzed revealing that the malfunction could be due to a can bus interruption or to a malfunction of the can interface of the pump.Considering that functional tests on pumps did not reveal any issue and that the same issue occurred on different pumps connected ad the same port of the e/p pack, a malfunction of the two roller pumps can be reasonably excluded as root cause of the event.For this reason, the e/p pack was requested back to manufacturer site for investigation.No defect/deviation could be reproduced or identified and the e/p pack was found to be working within specifications.As per equipment maintenance interventions prevention the two system boards will be replaced.Based on livanova service technician intervention findings, complaint history review, serial read-out analysis and functional tests, the malfunction could be restricted to a can bus interruption.In conclusion, the root cause of the reported pump stop was a can bus interruption that was most likely due to external interference from other devices or to an intermittent failure of the system boards of the e/p pack.

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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 11958276
• MDR Text Key: 254884162
• Report Number: 9611109-2021-00306
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2006
• 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