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

Model Number HL-CA10-00-000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

This patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Medical intervention was required to prevent further patient injury.During emergency use hemolung therapy, it was reported that patient experienced bleeding at catheter insertion site.Alung technologies, inc.Reports that medical staff called asking if they could hold heparin and how long before the circuit would clot.Alung advised them that they could hold the heparin as per their standard practice in light of bleeding.Also advised a certain time period before the circuit might clot is unpredictable.Offered to contact the medical monitor if they would like to discuss options.They felt comfortable holding heparin and would discuss with physician.The data log from hemolung 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.Hemolung therapy was provided as intended.No capa was opened because of this event.Bleeding at catheter insertion site a known possible occurrence with extracorporeal hemolung therapy.Examination of the controller data log shows 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.

Event Description

Alung technologies, inc.Reports that medical staff called asking if they could hold heparin and how long before the circuit would clot.Alung advised them that they could hold the heparin as per their standard practice in light of bleeding.Also advised a certain time period before the circuit might clot is unpredictable.Offered to contact the medical monitor if they would like to discuss options.They felt comfortable holding heparin and would discuss with physician.

• 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: 16200032
• MDR Text Key: 307658193
• Report Number: 3009763347-2023-00060
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00850046004179
• UDI-Public: (01)00850046004179(17)200501
• 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: Health Professional,User Facility
• 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 Expiration Date: 05/01/2020
• Device Model Number: HL-CA10-00-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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): Required Intervention; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Male