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 11/26/2020

Event Type  malfunction  

Event Description

Alung technologies, inc.Received a report that during eua hemolung therapy, staff experienced a downstream occlusion alarm on the infusion pump.Site staff reported that the infusion pump was off for an unknown period of time and was unsure why the pump had been off.The occlusion was cleared with clinical support and the site staff was satisfied with support provided.This was likely user error with the infusion pump off for an unknown amount of time.

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).It was reported that during eua hemolung therapy, staff experienced a downstream occlusion alarm on the infusion pump.Site staff reported that the infusion pump was off for an unknown period of time and was unsure why the pump had been off.Support was provided in which they were instructed to verify the clamp on the iv tubing was open, to disconnect the iv tubing from the cartridge and attempt to flush the port with a syringe.There was initial resistance to the flushing, but ultimately was successful.The user was then instructed to reconnect the iv tubing and select "run" on the infusion pump.The pump then continued to run without issue.Site staff was satisfied with support provided.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.No capa was opened because of this event.No clinical complications were reported as to have occurred as a result of this issue.Examination of the controller data log shows that therapy was provided as intended.The occlusion was cleared with clinical support and the site staff was satisfied with support provided.This was likely user error with the infusion pump off for an unknown amount of time.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: 16211936
• MDR Text Key: 308937102
• Report Number: 3009763347-2023-00091
• 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: 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: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 48 YR
• Patient Sex: Male