MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problem Pumping Problem (3016)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mastroller pump 150.The incident occurred in germany.Through follow-up communication livanova learned that initially the issue claimed by the customer was related to the s5 mast roller that ran irregularly and beat during priming, only with tubing inserted.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the issue: the pump ran smoothly without any vibrations; no failures occurred on the can bus.Hose guide rollers were renewed due to possible contact with the pump housing (raceway).Subsequent functional verification testing was completed without further issues and the unit was returned to service.The serial read-out of the pump (real time device parameters and setting recording file) was analyzed and the motor failure error was stored in the pump microcontroller and occurred on november 27th, 2023 between 7 a.M.And 8 a.M.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 mast roller pump gave a motor control failure error message during priming.It cannot be excluded that the pump stopped.There was no patient involvement.

Manufacturer Narrative

H10: complaints database analysis revealed no similar event since unit installation in 2019.Based on the investigation's results carried out for similar events, the stored motor control failure error code can be due to: - a disconnection between motor control board (hms) and computer board (hkr); - a defective motor control board (hms); - a defective computer board (hkr); - an excessive over-occlusion.Also motor control board (hms) and its connection to the motor have been verified by livanova field service representative and no deviation was identified.Therefore, it cannot be ruled out that the over-occlusion was the most likely root cause of the motor control failure occurred.The not smooth run of the pump instead was caused by tube guide rolls that were not properly in place due to a small gap between the metal pin and the guide roll that was explaining the slight noise noticed by customer.This gap was reasonably due to premature wearing.However, no trend of similar issue has been observed by the review of the post market data and no additional action is needed.

Event Description

See initial report.

• Brand Name: SRD S5 MAST ROLLER PUMP 150
• 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: 18381747
• MDR Text Key: 331486454
• Report Number: 9611109-2023-00654
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)190607
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• 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