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

Model Number 28-95-80

Device Problem Unexpected Shutdown (4019)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Livanova received report that the control panel of a s5 mast roller pump (mrp) turned off during the setup for a case.The biomedical engineer of the hospital toggled the power switch on and off multiple times on the mrp control panel, but the display never came back on.The biomedical engineer then moved the mrp control panel cable from port 10 to port 12 on the ep pack.This seemed to correct the issue and restored power to the mrp control panel.It was assumed that port 10 on the ep pack was faulty.It was reported that it is unknown if the pump had also lost power or just the display on the mrp control panel, because the pump was not in use at the time of this failure.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The mrp control panel and pump were fully functional and operating as per specifications.All connections of the control panel were checked and reseated as well as for the ep pack.As precaution it was decided to remove the control panel from the console and moved it to another.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: based on available information and service activity results, the root cause of the reported event is most likely related to false electrical contact between the mast roller pump control panel cable and and the port of the ep pack.

Event Description

See initial report.

• Brand Name: S5 MAST 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: 14596527
• MDR Text Key: 293343434
• Report Number: 9611109-2022-00288
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: (01)04033817900818(11)150814
• 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: 06/03/2022

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: 28-95-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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