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

Model Number HL-CR3-01-000

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

Patient Problems Cardiac Arrest (1762); Septic Shock (2068); Cardiogenic Shock (2262)

Event Date 07/12/2016

Event Type  Death  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Medical intervention was used in an attempt to avoid further patient injury but the end result was death that was unlikely to be related to the use of the hemolung device.It was reported that the patient experienced shock secondary to sepsis and cardiogenic.Three hours after start of therapy, patient began to deteriorate (decreasing blood pressure).Inotropic support increased over next ten hours (to maximum).Likely cause according to clinical team is sepsis and possibly cardiogenic shock.Due to refractory hypotension clinical team made patient dnr, but organ support continued.22 hours after randomization, patient arrested and death occurred.This event led to patient death but was unlikely to be related to use of the device.No capa was opened because of this event.Shock is a known potential complication that can occur during extracorporeal therapy and in general critically ill patients.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 shock secondary to sepsis three hours into hemolung therapy.This was indicated by the patient beginning to deteriorate (falling blood pressure).The clinical team relayed to alung technologies, inc.That this was possibly cardiogenic shock.Inotropic support increased over the next ten hours to the maximum amount.Due to refractory hypotension the clinical team made the patient dnar but organ support continued.22 hours after the commencement of the study the patient arrested and died.

• 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: 16211882
• MDR Text Key: 307765810
• Report Number: 3009763347-2023-00084
• 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: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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; Death; Required Intervention
• Patient Sex: Male