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 01/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Medical intervention was required to prevent further patient injury.An event was reported in which the subject experienced acute blood loss.Oozing at catheter site, despite attempts to control with surgical gauze.An additional suture was placed and oozing resolved.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Approximately one hour into hemolung therapy, the controller began alarming that air was in the blood line.After careful observation, it was determined that there was no air in the blood line.Site staff successfully switched hemolung therapy to a backup controller without issue.The data log for the remainder of the hemolung therapy show that co2 removal and blood flow graphs were as expected.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.Acute blood loss with bleeding at the catheter site is a known possible occurrence with 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 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 that bleeding was noted at the catheter site of the hemolung catheter during a procedure and continued despite attempts to control with surgical gauze.An additional suture was placed and bleeding resolved.

• 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: 16189488
• MDR Text Key: 307558901
• Report Number: 3009763347-2023-00039
• Device Sequence Number: 1
• Product Code: DQR
• 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: Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: HL-CA10-00-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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 Outcome(s): Life Threatening; Required Intervention