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

Model Number HL-CR4-01-000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/11/2020

Event Type  Injury  

Event Description

Alung technologies, inc.Received a report of a patient experiencing oozing blood at the insertion site.Dressing change was completed.Event resolved.

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 memphis, tennessee.Medical intervention was necessary to prevent further patient injury.An adverse event was reported in which the subject experienced oozing blood at insertion site.The dressing was changed completely.The event resolved.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.No abnormalities were noted within the co2 removal and blood flow graphs.No critical errors occurred.Therapy was provided as intended.No capa was opened because of this event.Bleeding a known possible occurrence with extracorporeal therapy.Examination of the controller data log shows that therapy was provided as intended.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.

• 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: 16189468
• MDR Text Key: 307558953
• Report Number: 3009763347-2023-00037
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2023

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 Operator: Health Professional
• Device Model Number: HL-CR4-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• 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): Life Threatening; Required Intervention