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

Model Number HL-CA10-00-000

Device Problem Defective Component (2292)

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

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4), florida.There was no report of patient injury.During catheter placement of an eua hemolung therapy, it was reported that the guidewire kinked.The catheter was inserted over the guidewire, but there was difficulty in advancing the catheter.The catheter was removed and the tissue was dilated again.Another attempt was made to advance the catheter, but when attempting to remove the wire, it would not retract.A wire from a central line kit was then used to catheterte the vessel, and then the catheter and guidewire were removed.The guidewire was kinked and had to be pulled through the distal end of the catheter to remove it.A guidewire from a spare catheter kit as well as the catheter already in use were used to successfully catheterte the patient.While there was still difficulty advancing the catheter during the successful catheter, the angle of approach was adjusted and the catheter was able to advance.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.Consistent blood flow and co2 removal were observed in review of the graphs.Therapy was provided as intended.There were no clinical complications reported as to have occurred as a result of this issue.No capa was opened because of this event.Guidewire kinking is a known possible complication that can occur during the catheter process.There are many factors that can contribute to the possibility of experiencing a guidewire kink.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 while providing phone support the hemolung catheter was inserted over the guidwire but there was difficulty advancing the catheter.The catheter was removed and tissue dilated again.Another attempt was made to advance the catheter.This time the catheter was advanced but when attempting to remove the wire it would not retract.A wire from a central line kit was then used to cathete the vessel then the catheter and guidewire were removed.The guidewire was kinked and had to be pulled through the distal end of the catheter to remove it.There was no report of patient injury.

• 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: 16200039
• MDR Text Key: 309025083
• Report Number: 3009763347-2023-00066
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004179
• UDI-Public: (01)00850046004179(17)200501
• 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: 01/18/2023

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-CA10-00-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female