MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problem Failure to Auto Stop (2938)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 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 level sensor was tested repeatedly and no deviations could be identified.Pump serial read-out analysis revealed the occurrence of two level alarms and that the pump did not stop.The pump didn't stop until the speed control knob was turned to zero.Thus, the reported event could be confirmed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a s5 master roller pump did not stop to a level alarm during service.Reportedly, the procedure started at 14:14 on (b)(6) 2022.It was reported that level sensor malfunction occurred at 15:01.In detail, the level sensor did not stop the arterial pump even if the level was low.There was no patient injury.

Manufacturer Narrative

H10: the serial read-out of the pump (real time device parameters and setting recording file) was analyzed.In detail: at 02:55p.M.The pump was stopped by the level alarm and at 03:00p.M.The rpm of the pump was turned down to zero; the reported issue occurred at 03:01p.M.And was not recorded.It is possible that the user overrode the level alarm (at 02:55p.M.) and when it was noticed that there was an alarm, the speeof the pump was turned down manually.Override of the pump, if occurred, could not be recorded in the serial read-out of the pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2010.Based on technical service activity and investigation results of similar complaint , it cannot be ruled out that the reported issue can be traced back to a user error consisting in the override of the alarm.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15860694
• MDR Text Key: 304279541
• Report Number: 9611109-2022-00609
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 11/23/2022

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: 10/26/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 03/17/2023
• Supplement Dates FDA Received: 01/17/2023; 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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
• Patient Sex: Male