MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19

Model Number HL-CR4-01-000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in dalton, georgia.There was no patient injury as a result of this malfunction.It was reported that during eua therapy, staff experienced an issue during priming.The user had just finished priming the circuit, and the blue end of the circuit tubing fell off of the barbed connecter at the recirculation bag.The user quickly clamped the tubing and no air circulated to the pump.The user was able to reconnect the tubing and go back through the priming steps to facilitate the removal of the air.The air was removed without further issue and the circuit was then properly primed and ready for connection to the patient.Staff was satisfied with training that enabled them to troubleshoot during occurrence of issue.Therapy was able to then commence without issue.No clinical complications were reported as to have occurred as a result of this issue.This is not a recurring issue and alung will continue to monitor for future reports.Alung will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung 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 during hemolung ras eua therapy the circuit tubing was loose and fell off the barbed connector on the recirculation bag of the hemolung device.The user quickly clamped the tubing and no air circulated to the pump.The tubing was then reconnected and priming again occurred to facilitate the removal of air.The air was removed without further issue and the circuit was properly primed and ready for connection to the patient.Therapy was then able to commence without issue.There was no patient injury as a result of this malfunction.

• Brand Name: HEMOLUNG RAS
• Type of Device: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane st.; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st.; suite 1; pittsburg, PA 15203
• MDR Report Key: 16164953
• MDR Text Key: 308480794
• Report Number: 3009763347-2023-00004
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)200101
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-CR4-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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 Age: 73 YR
• Patient Sex: Female