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 Defective Component (2292)

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

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in stevenage, united kingdom.It was reported that during therapy, staff experienced a critical 102 error.The controller responded appropriately by stopping the blood pump.Customer service was provided in which they advised to disconnect the o2, restart the controller, and evaluate the circuit.However, after inspecting the circuit, the physician felt it was unsafe to attempt to restart therapy.Customer support was provided through ending therapy.The patient was assessed the following day and the site staff confirmed the patient was seemingly unaffected by the issue with the control.Following the discontinuation of therapy, a replacement controller was installed and testing without issue.Site staff was satisfied with the support provided and the equipment replacement.The removed cr4 controller was returned to avensys for repair.Through review of the data log, it was determined that there was a leak from the oxygen sweep gas.This controller was recertified, with tubings replaced, and passed all testing without 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.Site staff was satisfied with the support provided and there were no clinical complications reported as to have occurred as a result of the alarm.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.

Event Description

Alung technologies, inc.Received a report that during eua hemolung therapy, staff experienced a critical 102 error.The controller responded appropriately by stopping the blood pump.Customer service was provided in which they advised to disconnect the o2, restart the controller, and evaluate the circuit.However, after inspecting the circuit, the physician felt it was unsafe to attempt to restart therapy.Customer support was provided through ending therapy.The patient was assessed the following day and the site staff confirmed the patient was seemingly unaffected by the issue with the control.

• 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: 16211821
• MDR Text Key: 308767596
• Report Number: 3009763347-2023-00074
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)180502
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: DEN210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2020
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female