MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL

Model Number HL-CR4-01-000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/30/2020

Event Type  Death  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in gainesville, florida.Medical intervention was required to prevent further patient injury.Alung technologies, inc.Received a report that a health professional was concerned for hemorrhagic shock in a patient due to acute blood drop/hypotensive.Pressors administered and transfusion was required.A large left groin hematoma noted with active bleed.Emergent central venous line was placed, high dose vasopressors and major transfusion protocol required.Common femoral artery was repaired in the operating room post-operation.This event is possibly related to use of the device and eventually led to patient death.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Approximately one hour into hemolung therapy, the controller began alarming that air was in the blood line.After careful observation, it was determined that there was no air in the blood line.Site staff successfully switched hemolung therapy to a backup controller without issue.The data log for the remainder of the hemolung therapy show that co2 removal and blood flow graphs were as expected.Hemolung therapy was provided as intended.The returned device was evaluated for any abnormalities.There were no findings within the analysis.There were no mechanical indications that the device would have malfunctioned.No capa was opened because of this eveny.Hemorrhagic shock is a known possible occurrence with hemolung therapy.Examination of the returned disposables as well as the controller data log show that hemolung therapy was provided as intended.Alung technologies, inc.Will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.Complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.

Event Description

Alung technologies, inc.Received a report that a health professional was concerned for hemorrhagic shock in a patient due to acute blood drop/hypotensive.Pressors administered and transfusion was required.A large left groin hematoma noted with active bleed.Emergent central venous line was placed, high dose vasopressors and major transfusion protocol required.Common femoral artery was repaired in the operating room post-operation.This event is possibly related to use of the device and eventually led to patient death.

• Brand Name: HEMOLUNG RAS
• Type of Device: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane st; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16200004
• MDR Text Key: 307656950
• Report Number: 3009763347-2023-00041
• Device Sequence Number: 1
• Product Code: QOH
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)180502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL-CR4-01-000
• Device Catalogue Number: S043275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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): Life Threatening; Death; Required Intervention