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); Multiple Organ Failure (3261)

Event Date 05/13/2015

Event Type  Death  

Manufacturer Narrative

(b)(4) is an exporter.

Event Description

This report is being provided as a result of fda 483 file number 3009763347 observation 1.The details of the patient condition are: per (b)(6) the patient experienced bowel ischemia with unknown relation to hemolung therapy.Awaiting further information.Update: the treating physician feels the likelihood of the hemolung transferring an air embolus or blood clot directly to the bowel is very low.An echo showed no patent forman ovale.The cartridge and catheter were examined post use by the physician and paul turner ans appeared remarkable clean with no evidence of clotting.The patient did die of multi-organ failure post-hemolung use.Tga was notified and the final closure report from tga was received by alung.

• 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 INC.; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer Contact: frank falcione ; 2500 jane street; suite 1; pittaburgh, PA 15203 ; 4126973370
• MDR Report Key: 6602679
• MDR Text Key: 76319901
• Report Number: 3009763347-2017-00003
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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

• 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: 05/14/2015
• 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