MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Difficult to Open or Close (2921)

Patient Problems Cardiac Arrest (1762); Nervous System Injury (2689)

Event Date 03/21/2023

Event Type  Death  

Manufacturer Narrative

A.1-a.5.: patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp / 620mm.The incident occurred in united kingdom.Through follow-up communication with customer, livanova learned that the event occurred at approximately 11:41am on (b)(6) 2023, the end user was turning down the flow rate of the cp5 drive unit when an alarm sounded: multiple error messages appeared in the system panel shortly afterwards (clamp, level, bubble and pressure).Flow display on cp5 system was seen to be '0' or close to'0'; flow was re-established after approximately 14minutes.One of the errors was cleared.It was also observed that the 'open clamp' and 'close clamp' buttons were no longer present in the cp5 display.The final error message in the s5 system panel, after others were cleared, was seen to be 'arterial clamp defective'.This error message was not visible until the other error messages were cleared , the s5 system was powered-on and initial observations were that the 'open clamp' and 'close clamp' buttons were in the cp5 display and operated satisfactorily.Customer set about clearing the visible error messages one by one, and also attempted hand cranking not realizing that s5 erc tubing clamp was still closed.This could be also the cause of interruption of bypass lasted fourteen (14) minutes.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue related to clamp failure.No issue found: cp5 system and s5 erc tubing clamp worked correctly and as expected.Also connections and cabling were checked: no anomaly found.Subsequent functional verification testing was completed and the unit was returned to service.The serial read-out of the cp5 system (real time device parameters and setting recording file) was extracted and on the time and date of event there are error messages stored compatible with ¿arterial clamp defective¿ issue.The exact root cause of this fault/incident cannot be determined at this moment.Further investigation of the serial readouts, and the hardware, need to be carried out.In the days following the event, patient¿s condition were considered serious: eyes were fixed and dilated, only slight improvement.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 deutschland received a report that a failure of a s5 electrical remote-controlled (erc) tubing clamp during bypass procedure, that was stopped for approximately fourteen (14) minutes.Then s5 system gave several alarms.On (b)(6) 2023, livanova was informed the patient has died.

Manufacturer Narrative

H10: through the analysis of the cp5 serial readout and the serdat file of connect, it was identified that at 11:41:07 the clamp error message was triggered, and at 11:41:20 the level alarm was on, followed by the pressure alarm at 11:44:36, and the bubble alarm at 11:44:45.As per the perfusionist report, the medical staff proceed by clamping the venous line to avoid patient exsanguination, in addition, the arterial line was checked for misplacement of the surgical and perfusionist tubing clamps, and the tubing was visually inspected to rule out any kinks.Then the staff decided to start the hand crank, but the systemic blood flow was not achieved despite it.Finally, the perfusionist recognized the error message ¿arterial clamp is defective¿ once the other alarms were cleared, meaning that the perfusionist didn¿t act on the system panel to scroll the entire alarm list previously.Then it was also noted that the erc open/close icons were not available on the cp5 control panel.After approximately 14 minutes of troubleshooting, the perfusionist finally checked the erc status recognizing that it was closed and restored the forward systemic flow by manually opening the erc.As per device instructions for use, livanova erc devices are equipped with a handle aimed at the manual opening of the clamp, releasing the engaged tube and restoring the flow.Therefore, in case of an undesired closure of the automatic clamps, it is always possible to act on the handle to prompt perform a manual opening.Based on livanova technical intervention, it cannot be excluded that the erc error was related to cable temporary loose connection between the clamp control board and the s5 system, also confirmed by the absence of the erc open/close icons on the display.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2011.In conclusion, the patient's death has been alleged to be related to the procedure and based on all the above facts, the stopping of the flow was a consequence of the disconnection of the erc cable, properly detected and shown with specific alarm by the device.This failure was belatedly recognized by the perfusionist who didn¿t timely troubleshoot it.

Event Description

See initial report.

Manufacturer Narrative

Investigation has been completed.Event reported to livanova on march 21st, 2023, was related to bypass procedure stopped for about 14 minutes, during when no blood flow was possible.During this period multiple alarms were triggered by hlm s5 perfusion system, the first was related to erc clamp stuck properly identified by hlm s5 perfusion system that displayed ¿arterial clamp is defective¿ message on the system panel late recognized by user because did not act on the system panel to scroll the entire alarm list, as suggested by instruction for use.Analysis of diagnostic real-time data was able to confirm that erc clamp stuck in closed position and other alarms consequently were triggered by the system.The analysis of post-market data identified that, since 2020, a total of 132 events related to erc clamp stuck were reported to livanova over a total of 5,418,240 procedure performed, none related to consequence for the patient with exception of current case.The investigation performed on parts involved in the complaint and returned was able to identify as root cause of the stuck the reduced performance of lubricant in the erc clamp motor related to wearing as consequence of liquid penetration and 12 years aging.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The present follow up is being submitted to amend the previous report and provide better explanation of the root cause.The cause of the reported event is not the aging of the device and rather the ingress of liquid potentially occurring during the period in which the device was in use which in this specific case is 12 years.The reason for liquid penetration is more likely due to non-adherence to the instructions for use regarding cleaning and maintenance at paragraph 5.2 cleaning and disinfecting.According to s5 manual "the maintenance check must be carried out on the s5 system every 1000 operating hours or every 12 months (whichever comes first)." s5 operating instruction used by the customer does not provide a defined limit for the service life and it requires the periodic execution of the checks foreseen by preventive maintenance.Although there is no define limit for the expected service life for this device when maintained in accordance with the instructions for use, the usual service life for this type of product is normally around 10 years.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16751637
• MDR Text Key: 313420453
• Report Number: 9611109-2023-00176
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• 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,Followup,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death