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 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4), united kingdom.Shortly following initiation of hemolung therapy, the controller alarmed with elevated cabinet o2.O2 was running as sweep gas.The staff was advised to switch to using air for the sweep gas, which resolved the issue.However, four hours later hemolung therapy was attempted to return to o2 for the sweep gas as the patient was hypoxic.But the controller began again alarming with elevated cabinet o2.Support was provided in which the staff was advised to continue hemolung therapy with room air as the sweep gas.The data log was retrieved and reviewed by both clinical and software engineering staff.The software engineering review suggest a possible leak in the vacuum pump / sweep gas module, as opposed to a faulty o2 sensor.The controller was exchanged and repaired.The clinical review shows no abnormalities were noted within the co2 removal and blood flow graphs.Hemolung therapy was provided as intended.No capa was opened because of this event.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 shortly after hemolung therapy started the hemolung device started alarming 'high cabinet o2 levels'.O2 was running as sweep gas.The site was advised by support to continue hemolung therapy with room air as the sweep gas.There was no report of patient injury because of this issue.

• 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: 16200023
• MDR Text Key: 308975209
• Report Number: 3009763347-2023-00055
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)171102
• 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: 01/18/2023

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?: 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: 04/26/2020
• 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