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

Model Number 10-88-60

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).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 (b)(4) received a report that a s5 mast roller pump was giving a motor control failure error message during procedure.The error disappeared after switching off/on twice the pump control panel.There was no report of patient injury.

Manufacturer Narrative

H.10: the serial read-out of the roller pump was analyzed and the reported error message could be confirmed.It cannot be ruled out that a defective processor board had caused the problem.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for repair.The circuit boards were replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to defective pump circuit boards.

Manufacturer Narrative

H.10: in the previous report the following was incorrectly reported: "the affected device was returned to the manufacturer site for repair.The circuit boards were replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to defective pump circuit boards." please consider valid the statement below: " the affected device was returned to the manufacturer site for repair.The can cable connected to the processor board was replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to a broken cable.Subsequent functional verification testing was completed without further issues and the unit was returned to service.".

• Brand Name: S5 MAST 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: 11019112
• MDR Text Key: 221825243
• Report Number: 9611109-2020-00688
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K062396
• 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,Followup,Followup
• Report Date: 02/12/2021

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: 10-88-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 12/01/2021; 02/25/2022
• Supplement Dates FDA Received: 02/12/2021; 12/28/2021; 03/25/2022
• Date Device Manufactured: 09/14/2019
• 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