MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG CATHETER KIT

Model Number REF 30100

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

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 04/02/2016

Event Type  Death  

Event Description

This report is a result of (b)(4) and ecporter receiving a 483 file number (b)(4) - observation 1.The summary of the event is as follows: after multiple attempts to retrieve information from the treating physician, (b)(4) received the hemolung registry form from dr.(b)(6), on (b)(6) 2016.The physician indicated that the cerebral hemorrhage and subsequent death were definitely related to hemolung therapy secondary to the need for anticoagulation.Dr.(b)(6) indicated the hemolung device was functioning as expected allowing for improved lung protective ventilation with desired co2 removal.Out of an abundance of caution, (b)(4) is reporting this incident.More information is attempted to be gathered from dr.(b)(6) at this time.Hemorrhage is, again, a known complication of any extracorporeal device, including the hemolung ras, due to the required need of heparin for anticoagulation purposes.These complications are covered in hemolung trainings and are labeled appropriately in the potential complications section of the hemolung ras instructions for use.(b)(4) continuously monitors for these types of reported complications and will continue to do so.This report was submitted to mhra and closed see attached report and closure letter.

• Brand Name: HEMOLUNG CATHETER KIT
• Type of Device: HEMOLUNG CATHETER KIT
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer (Section G): ALUNG TECHNOLOGIES; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer Contact: frank falcione ; 2500 jane street; suite 1; pittsburgh, PA 15203 ; 4126973370
• MDR Report Key: 6602757
• MDR Text Key: 76323652
• Report Number: 3009763347-2017-00007
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR