MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 06/26/2023

Event Type  Death  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova (b)(6) manufactures the s5 roller pump.The incident occurred in germany.A technical incident resulting in air entering the vascular system cannot be described.The fact is, however, that an air embolism was suspected in the postoperative course.This could not be proven by image morphology.Possible causes are the entry of air via the various vascular accesses or cannulations of the vessels as well as directly via the opening of the heart.Bubble sensor was used and not on the cardioplegia line.No audible or visual alarm was present.According to preliminary evaluation, last preventing maintenance of the s5 was in (b)(6) 2023 and no hardware deviation reported during maintenance.No livanova technician checked the hlm after the case.From reported information involved pump was used for cardioplegic delivery and bubble sensor was not used even if from ifu it is advised to not operate cardioplegic control with bubble or pressure sensors disconnected (paragraph 5.6.4 cardioplegia control).Display on the sauga pump sn: (b)(6) has scratches, however all functions can be controlled on the display and display will not be replaced.Serial read out (real time device parameters and setting recording file) of the pump was collected and are under investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on (b)(6), 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on (b)(6), 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.

Event Description

Livanova deutschland has received a report that, during a procedure, more that 50 ml of air was delivered to the patient brain.This led to patient death on (b)(6), 2023.

Event Description

See initial report.

Manufacturer Narrative

Serial read out (real time device parameters and setting recording file) of the pumps were collected and investigated: roller: no data stored on date of event, probable data corruption during extraction roller vacuum: error on the can bus due to can malfunction, not relevant since the pump was used as sucker.Arterial roller: no data stored on date of event, probable data corruption during extraction cardioplegia roller: no data stored on date of event, probable data corruption during extraction no direct product relationship established.Cardioplegia infuse directly in the coronary and below arterial clamp.The flow from cardioplegia does not go to the patient.The only situation can be related to send blood and bubble to the patient is when cross clamp is removed and in this case this is a user error.From cpl to provide air to brain is an error.If the air is delivered to patient by cpl there are many way to remove the air.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: a device service history review has been performed and identified that the unit was manufactured in 2006 and no other similar event has been reported, neither concerning trend has been identified.Livanova maintains device history record (dhr) documentation that provide evidence of the production and control activities carried out during the manufacturing of the medical device according to device master record (dmr) specifications and procedures.For this specific case it is not deemed necessary to perform dhr review since contribution of possible native defects can be expected during first usages.Based on the information provided, most likely the cause of the reported death is an adverse event related to procedure and/or user error, but the exact dynamics of the error have not been determined.Based on all the above, a livanova device malfunction contributing to the issue can be excluded.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 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: 18490851
• MDR Text Key: 332601926
• Report Number: 9611109-2024-00022
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2006
• 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 Outcome(s): Death
• Patient Sex: Female