MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC HEMOLUNG CR3 CONTROLLER; HEMOLUNG CR4 CONTROLLER

Model Number REF 20000

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 09/08/2017

Event Type  Death  

Event Description

The patient died after suffering a cerebral bleed following hemolung therapy.

• Brand Name: HEMOLUNG CR3 CONTROLLER
• Type of Device: HEMOLUNG CR4 CONTROLLER
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC; 2500 jane street; suite 1; pittaburgh 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: 7319887
• MDR Text Key: 101794636
• Report Number: 3009763347-2017-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REF 20000
• Device Catalogue Number: REF 20000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2014
• 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): Death