MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL

Model Number HL-CR3-01-000

Device Problem Insufficient Information (3190)

Patient Problem Pleural Effusion (2010)

Event Date 02/04/2018

Event Type  Injury  

Manufacturer Narrative

This patient information was not provided.Alung technologies, inc manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Through review of the final clinical study adverse event listings, it was reported that a patient experienced pleural effusion.As no further notification was received regarding this adverse event, no further information is available.No capa was opened because of this event.Pleural effusion is a known potential complication that can occur during extracorporeal therapy and critically ill patients in general.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 of a patient experiencing fluid buildup between the chest cavity and the lungs after hemolung therapy ended.No further information was provided.

• Brand Name: HEMOLUNG RAS
• Type of Device: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
• 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: 16211932
• MDR Text Key: 307765053
• Report Number: 3009763347-2023-00088
• Device Sequence Number: 1
• Product Code: QOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: DEN210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL-CR3-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Outcome(s): Other
• Patient Sex: Male