MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; CANNULA, CATHETER

Model Number HL-CA09-00-000

Device Problem Defective Component (2292)

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

Event Date 04/17/2020

Event Type  malfunction  

Event Description

Alung technologies, inc.Received a report that a health professional experienced a failed catheter attempt with a hemolung catheter.The catheter procedure was aborted after arterial injury was suspected.The guidewire found to be moderately kinked upon removal.No apparent device failure noted.

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4), kentucky.Alung technologies, inc.Received a report that during emergency use hemolung therapy, a catheter attempt was made.The first catheter attempt was of the right femoral artery.The femoral site was chosen due to location of existing dialysis catheter placement in right intrajugular.Arterial injury was suspected during final dilation, and the catheter was aborted to evaluate/treat the patient.Upon removal, the guidewire was found to be moderately kinked.The bleeding stopped and the vascular surgeon evaluated the patient with no hematoma or bleeding noted.Thus the catheter procedure was then continued.Following successful catheter, shortly after initiation of hemolung therapy, a low co2 removal alarm was observed on the controller.The physician increased the rpm settings on the controller to optimize the blood flow.The increased blood flow increased the co2 removal rate above the alarm threshold.The controller alarmed as appropriate in response to the rate.The data log from hemolung 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.No unexpected alarms or errors occurred.Hemolung therapy was provided as intended.No capa was opened because of this event.Guidewire kinking is a known possible complication associated with the catheter process.Arterial injury is a known possible complication associated with the catheter process as well.Examination of the controller data log shows that hemolung 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: CANNULA, CATHETER
• 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: 16200025
• MDR Text Key: 308934097
• Report Number: 3009763347-2023-00056
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00850046004162
• UDI-Public: (01)00850046004162(17)220101
• 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 Expiration Date: 01/01/2022
• Device Model Number: HL-CA09-00-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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: 43 YR
• Patient Sex: Female