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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/02/2020

Event Type  malfunction  

Event Description

Alung technologies, inc.Received a report that during eua hemolung therapy, staff observed air entrained into catheter and circuit upon therapy start-up.There was no air observed in the system during recirculation mode and no fracture/holes in the catheter upon inspection by the experienced treating physician and assistant.The air entrapment was likely not device or disposable related based on the troubleshooting steps taken.The issue resolved following change of the catheter site.Overall, troubleshooting included re-catheter (twice) and switching therapy to a backup controller.There was no report of patient injury.

Manufacturer Narrative

Patient identifier, weight, ethnicity, race.This patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).It was reported that during eua hemolung therapy, staff observed air entrained into catheter and circuit upon therapy start-up.There was no air observed in the system during recirculation mode and no fracture/holes in the catheter upon inspection by the experienced treating physician and assistant.Following the first ij catheter of the day, therapy initiated and 30-40 seconds later, air was observed in the circuit.Tubing and catheter were clamped before the air was able to reach the patient return.Blood aspirated without air from existing ij, so therapy was reinitiated with second circuit and second controller of the day (same ij catheter).Therapy initiated and 30-40 seconds later, air was again observed.The circuit and catheter were clamped and the ij was removed for inspection.There were no findings following inspection by experienced hemolung users.The second ij catheter for the day was the inserted with existing circuit and controller, but the issue was again observed.Patient had picc in place with all three lumens in use.The third and final catheter of the day was femoral, using the existing circuit and controller.Therapy then initiated without issue.The air entrapment was likely not device or disposable related based on the troubleshooting steps taken.The issue resolved following change of the catheter site.Overall, troubleshooting included re-catheter (twice) and switching therapy to a backup controller.Site staff was satisfied with support provided.Follow up discussion was provided to the treating physician to discuss the situation and events around this issue, but the physician was unsure of the cause of this issue.The data log from 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.Therapy was provided as intended.This is not currently a recurring issue; alung technologies, inc.Will continue to monitor for future reports of this occurring.No clinical complications were reported as to have occurred as a result of this issue.No capa was opened because of this event.Examination of the controller data log shows that 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 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; pittsburgh, PA 15203
• MDR Report Key: 16211816
• MDR Text Key: 308836166
• Report Number: 3009763347-2023-00071
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)180729
• 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: 01/19/2023

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?: 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: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2018
• 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 Age: 76 YR
• Patient Sex: Male