MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RESPIRATORY ASSIST SYSTEM

Model Number REF 30100

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

Patient Problems Death (1802); Hemolysis (1886); Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261)

Event Date 08/08/2014

Event Type  Death  

Manufacturer Narrative

This report is being provided as a result of fda 483 file number 3009763347 - observation 1.The final summary is included in the final incident report and is summarized below.Based upon final information provided by the physician, alung cannot definitively relate the patient's cause of death -- multi-organ failure -- to the use of the hemolung device.This is the first report of its kind.Alung will continue to proactively monitor these types of events.The incident report was closed by (b)(6).

Event Description

As first reported on 18 august 2014, alung received a brief report of a patient death unrelated to the hemolung ras on (b)(6) 2014.The exact cause of the death cannot yet be determined.An autopsy was not performed.The hemolung cartridge and catheters could not be returned for further explant analysis.Additional information from the treating physician could only be obtained on (b)(6) 2014, due to the physician's schedule.On (b)(6) the physician reported a (b)(6) year old female who was on invasive mechanical ventilation experienced carbon dioxide retention, and he sought to use the hemolung ras device as an adjunct to the ventilator in order to correct the patient's hypercapnia.The cannulation procedure was uneventful.At around hour 60, the patient experienced hemolysis and worsening procalcitonin and c-reactive protein (crp) levels.The patient did not experience a fever.Two units of erythrocyte concentrates and 5 units of platelets were given as a result of a bleeding event in the chest tube.Heparin levels were reduced from her bleeding.She was hemodynamically stable with modest levels of catecholamines.On day 5, the patient died of multi-organ failure while on hemolung.Hemolysis, bleeding, and inflammatory responses are included in alung's risk documentation, and are expected complications associated with extracorporeal therapies.On september 6, the physician could not offer a specific cause of death.Alung has not received any other similar reports of patients treated on the hemolung ras and this event appears to be an anomaly.Alung has requested additional data from the physician.The event remains under investigation.Manufacturer's follow-up report - 17 october 2014, alung has attempted to download and access the bfarm form from the website address: (b)(4) without success.This follow-up report is being submitted on a standard incident report form instead.Alung is still in the process of collecting information from the physician and this investigation remains open.The hemolung cartridge and catheters were disposed at the site in accordance with hospital policy and could not be returned for alung's investigation and analysis.

• Brand Name: HEMOLUNG RESPIRATORY ASSIST SYSTEM
• Type of Device: HEMOLUNG RESPIRATORY ASSIST SYSTEM
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer (Section G): ALUNG TECHNOLOGIES INC.; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer Contact: frank falcione ; 2500 jane street; suite 1; pittsburgh, PA 15203 ; 4126973370
• MDR Report Key: 6602635
• MDR Text Key: 76317746
• Report Number: 3009763347-2017-00002
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: REF 30100
• Device Catalogue Number: REF 30100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 70 YR