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

Model Number 10-95-00

Device Problem Pumping Stopped (1503)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the essenz small roller pump.The incident occurred in göteborg, sweden.Through follow-up communication with the customer, livanova learned that the procedure started without any problem, checklist was performed completely with positive results and bypass started.2 suction pumps and 1 vent pump were used and suddenly the vent pump stopped.No problem in the raceway was detected, no kink, the occlusion was checked and it was fine.The cable was disconnected and reconnected to the power pack of the hlm system without success.It was noted that the pump head was hard to be turned.There was no patient impact, failure was solved by starting to use cell saver to increase blood aspiration.The serial read-out (real time device parameters and setting recording file) of both hlm cockpit and involved suction pump were analyzed.Analysis result for cockpit: an indication of ¿suction pump defective" was present although, given the logging limitation, it does not log the associated service error codes.The error code reported by the customer is not associated with possible ones related to ¿suction pump defective¿ alarm and, in addition, it is an internal error code used between control unit and essenz small roller pump and it is not shared with cockpit, therefore it is not possible that the user has read this code (2339) in the cockpit notifications.Most likely, he had misreported the code seen that was similar in terms of digits (2329) and different in term of issue.This last one is related to pump drive defective.Analysis result for control unit: no specific error code was identified.Some gaps were identified in the software in terms of logged events, however this would have been present by design in case of a runaway alarm.As investigation, the complained roller pump and its control unit were connected to an essenz hlm system and turned on.While the drive unit was mounted vertically, the accessory did not show the complained malfunction.In order to measure the current consumption of the motor, the drive unit was disassembled.The motor section was connected to an s5 test bench.For this test, the motor section was mounted in a horizontal position.After a few revolutions, the motor stopped with a scratching noise.The pump head was blocked.The motor section was disconnected from the test setup, the pump head was inspected visually: the guiding pin was touching the raceway of the pump head.This caused the blockage of the pump head and the scratching noise.There was also a gap between the guiding pin and the rotating part of the pump head.It was possible to unmount manually the guiding pin without using a tool.It was visible that the threads of the 7 guiding pins are contaminated with white powder.Due to the fact that the pin was loose, a physical analysis/investigation could not be performed to check the correct mounting torque and it can be indicated that the loose pin was mounted with little or no screw-locking adhesive.Based on the above analysis, most likely the error code 2329 was the actual message displayed as: 2339 is an internal code not visible to the user on the cockpit notification.2329 perfectly fit with the observed mechanical defect and was also reproduced in an internal test.The reported issue was caused by an unscrewed guiding pin scraping the pump raceway and creating a mechanical blockage to pump rotation.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 an essenz double head pump, used as suction pump, stopped during a pediatric case and gave a runaway error message (the pump ran too fast - set value different to actual value).The customer unplugged and re-plugged the connection cable of the involved pump, then the pump ran for twenty (20) seconds before stopping again and giving the same error message.There was no patient injury.

Event Description

See intial report.

Manufacturer Narrative

A dedicated non conformity report has been issued to address the operator error during the manual assembly phase.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ESSENZ SMALL ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16681605
• MDR Text Key: 312776021
• Report Number: 9611109-2023-00145
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)220210
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K221373
• 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: 06/20/2023

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: 10-95-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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