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

Model Number UNKNOWN

Device Problem Failure to Auto Stop (2938)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/11/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).Upon information, several days prior to the patient being connected to s5 system, a technician employed by hospital attempted to clean and reassemble the machine.Upon information and belief, the technician failed to properly and safely reassemble it.Defendants negligently failed to ensure the ecmo machine was safely reassembled and negligently failed to test it before putting it back in service and failed to test the machine before hooking the patient.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 (b)(4) received report that a 16-days old female patient died on (b)(6) 2020 at (b)(6) during an ecmo medical procedure while connected to a s5 system.S5 system was connected to patient neck helping patient blood to flow through the machine and her body.When the tubing of the machine dislodged, patient blood began to leak across the operating room and was noted at 10:26 am of (b)(6) 2020.Patient bled to death at 10:50 am following cpr, epinephrine, and transfusion with prbcs.The medical record reveals that when machine tubing became dislodged the machine alarm failed to sound.

Manufacturer Narrative

The use of s5 machine in ecmo is off label and it is responsability of the center to use the machine in ecmo.Complication occured when hospital personal cleaned and opened the device.There is no evidences of any responsability of livanova device.Dislodgement of cannula is independent form s5 machine.Good monitoring is something required in ecmo.There is no correlation with cannula and system used.The investigation is on-going.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

Based on the information provided, it is likely that it was a user error, but the exact dynamics of the error have not been clarified.Based on the analysis performed, it can reasonably exclude malfunctions of the s5 machine.No other specific action was currently deemed necessary.

• Brand Name: S5 SYSTEM
• 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
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16202465
• MDR Text Key: 307657646
• Report Number: 9611109-2023-00029
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 16 DA
• Patient Sex: Female