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

Model Number HL-CA10-00-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in iowa city, iowa.Medical intervention was required to prevent further patient injury.An adverse event was reported in which the subject experienced leakage of blood around the jugular catheter.A suture was removed and the catheter adjusted; the suture was replaced without issue.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.The co2 removal and blood flow graphs show that hemolung therapy was provided as intended.The returned device was evaluated for any abnormalities.There were no findings within the analysis.There were no mechanical indications that the device would have malfunctioned.No capa was opened because of this event.Bleeding at the catheter site is a known possible occurrence with extracorporeal hemolung therapy.Examination of the returned disposables as well as the controller data log show 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.

Event Description

Alung technologies, inc.Receieved a report of a patient experiencing a leakage of blood around the hemolung jugular catheter for hemolung therapy.The suture was removed and catheter adjusted; suture replaced without issue.

• 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: 16200024
• MDR Text Key: 307659219
• Report Number: 3009763347-2023-00054
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00850046004179
• UDI-Public: (01)00850046004179(17)191001
• 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: Study
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: HL-CA10-00-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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 Outcome(s): Required Intervention; Life Threatening