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

Model Number HL-CR4-01-000

Device Problem Device Handling Problem (3265)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4), massachusetts.During therapy, a clinical study patient experienced hypotension.Alung was not initially made aware of this event as this was originally reported as not meeting criteria of seriousness and unrelated to use of the device.The device causality was indicated to be probably related as this was probably related to line placement of device.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.Consistent blood flows and co2 removal were observed throughout therapy.There were high blood flow alarms intermittently throughout therapy, but rpms were adjusted accordingly.There were no unexpected alarms or critical errors.Therapy was provided as intended.Hemodynamic instability is a known possible occurrence with use of extracorporeal therapy and/or critical illness.Examination of the controller data log shows that therapy was provided as intended.Alung 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 of a patient experiencing hypotension during hemolung ras therapy.Norepinephrine medication was administered.Hemolung therapy was not discontinued as a result of this event.

• 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: 16163820
• MDR Text Key: 307465877
• Report Number: 3009763347-2023-00008
• Device Sequence Number: 1
• Product Code: QOH
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)190328
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL-CR4-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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): Life Threatening; Required Intervention