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 04/17/2020

Event Type  Injury  

Event Description

Alung technologies, inc.Receieved a report that a patient experienced hemorrhagic shock during emergency use hemolung therapy.Medication was given and a blood transfusion occured.The patient became hemodynamically unstable and coded during vascular repair in or.The patient was stabilized and the procedure completed.

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in louisville, kentucky.Medical intervention was required to prevent further patient injury.During emergency use hemolung therapy, the patient experienced hemorrhagoc shock.Site staff notified alung technologies, inc.Of a low blood flow alarm occurring on the controller.After two hours of hemolung therapy, the patient started to have massive bleeding from the right femoral artery.The low blood flow was likely related to hypotension and the expanding right groin hematoma.Echo confirmed arterial injury in right groin.The patient was treated with pharmacological support, multiple blood products, and the max settings on the hemolung.Once stabilized, the patient was transported to the or for arterial repair.Post repair, the blood flow stabilized and the alarm ceased.Thus, the controller operated as intended during the alarm.Alung technologies, inc.Was notified that during the arterial repair in the or, the patient experienced hemorrhagic shock in which the patient became hemodynamically unstable and coded.The patient was stabilized, the procedure completed, and the patient was then transferred.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.No abnormalities were noted within the co2 removal and blood flow graphs.No unexpected alarms or errors occurred.Hemolung therapy was provided as intended.No capa was opened because of this event.Bleeding, arterial injury, and hemorrhagic shock are known possible complications associated with the catheter process.Examination of the controller data log shows 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.

• 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: 16200026
• MDR Text Key: 307657896
• Report Number: 3009763347-2023-00057
• Device Sequence Number: 1
• Product Code: QOH
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)171101
• 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: Health Professional,User Facility
• 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

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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): Required Intervention; Life Threatening
• Patient Age: 43 YR
• Patient Sex: Female