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

Model Number HL-CR4-01-000

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

Patient Problem Respiratory Failure (2484)

Event Date 03/11/2021

Event Type  Death  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in boston, massachusetts.The event led to the patient being transitioned to comfort measures, and eventually patient death.During therapy, a clinical study patient experienced worsening mixed hypoxic and hypercarbic respiratory failure.Respiratory status continued to worsen after all therapeutic options had been exhausted.The family decided to transition the patient to comfort measures only.Alung was not initially made aware of the adverse event as it was originally reported as unrelated to use of the device and seriousness was not reported.Device causality was deemed unrelated to use of the 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.Following this adverse event, the patient was transitioned to comfort measures only and the patient subsequently expired.This event was unrelated to use of the device.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 worsening hypoxic and hypercarbic states leading to respiratory failure during therapy involving a hemolung ras.The patient was transitioned to comfort measures, given morphine, and this eventually led to patient death.

• 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 cole ; 2500 jane st.; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16163835
• MDR Text Key: 307455119
• Report Number: 3009763347-2023-00003
• 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: 12/02/2021
• 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): Required Intervention; Death; Life Threatening