MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; CANNULA, CATHETER

Model Number HL-CR3-01-000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Lot/serial number was not provided, so the udi and expiration date could not be determined.As lot number was not provided, manufacturing date could not be determined.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Through review of the final clinical study adverse event listings, it was reported that a patient experienced bleeding at the insertion site.As no further notification was received regarding this adverse event, no further information is available.No capa was opened because of this event.Bleeding is a known potential complication that can occur during extracorporeal therapy.Alung will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.

Event Description

Alung technologies, inc received a report of a patient experiencing bleeding at the catheter site during hemolung therapy.Therapy was still provided as intended.No further information was provided.

• Brand Name: HEMOLUNG RAS
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane st; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16189467
• MDR Text Key: 307558494
• Report Number: 3009763347-2023-00038
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: DEN21006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HL-CR3-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male