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 Hematuria (2558)

Event Date 02/23/2020

Event Type  Injury  

Event Description

Alung technologies, inc.Recieved a report of a patient experiencing pink urine post hemolung cateter placement.The catheter line was checked for kinkin and blood flow setting was decreased.Persistence of gross hematuria along with high pfh and other parameters led to decision to decatheterate.

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 minneapolis, minnesota.Medical intervention was required to prevent further patient injury.Alung technologies, inc.Recieved a report of a patient experiencing pink urine post hemolung cateter placement.The catheter line was checked for kinkin and blood flow setting was decreased.Persistence of gross hematuria along with high pfh and other parameters led to decision to decatheterate.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Review of blood flow and co2 removal graphs show that hemolung therapy was provided as intended without any unexpected alarms or malfunctions.The returned device was evaluated for any abnormalities.There were no findings within the analysis.There were no mechanical indications that the device would have malfunctioned.No capa was opened because of this event.Increased plasma free hemoglobin is a known possible occurrence with hemolung therapy.Examination of the returned disposables as well as the controller data log show that hemolung therapy was provided as intended.Alung technologies, inc.Will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.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: 16200005
• MDR Text Key: 307659341
• Report Number: 3009763347-2023-00043
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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