MAUDE Adverse Event Report: ALUNG TECHNOLOGIES INC. HEMOLUNG 15.5 JUGULAR CATHETER KIT; HEMOLUNG 15.5 FR JUGULAR CATHETER KIT

Model Number REF 30100

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

Patient Problems Death (1802); Exsanguination (1841); Respiratory Distress (2045); Respiratory Failure (2484); Loss Of Pulse (2562)

Event Date 03/17/2014

Event Type  Death  

Manufacturer Narrative

Refer to the incident report sent to (b)(6) competent authority.This emdr is a result of fda 483 file number 3009763347 - observation 1.Device not returned to manufacturer.

Event Description

Refer to the incident report submitted to (b)(6), competent authority.The final report is summarized below: the manufacturer's device analysis results: this (b)(6) year old critically ill female patient had a prior history of chronic ischemic heart disease and tight aortic stenosis.Prior to hemolung therapy, the patient underwent a coronary artery bypass graft and received a biologic aortic valve prosthesis.Two days later her respiratory failure was worsening.She became hemodynamically unstable and her acute respiratory distress syndrome (ards) was progressing making oxygenation and co2 removal difficult to achieve on invasive mechanical ventilation.Hemolung therapy was agreed upon by the patient's son to address her co2 retention.The physician followed standard cannulation procedures but the guidewire was advanced into the superior vena cava where it penetrated the vessel in a medial and ventral direction into the hilus of the right lung and into the proximal parts of the middle and inferior lung lobes.At autopsy, profuse amounts of blood were found in the trachea, right hilum and proximal parts of the mid and superior lobe.This hemorrhagic event caused acute circulatory collapse, asystole, and death.This event is a known risk of the cannulation procedure and is included in alung's risk documentation.Following the review of the physician's report and autopsy report, alung has determined that while this is a known complication, suboptimal catheter placement technique cannot be ruled out.This is our final report.

• Brand Name: HEMOLUNG 15.5 JUGULAR CATHETER KIT
• Type of Device: HEMOLUNG 15.5 FR JUGULAR CATHETER KIT
• 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: 6602577
• MDR Text Key: 76322589
• Report Number: 3009763347-2017-00001
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/17/2014
• 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: 75 YR
• Patient Weight: 50