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 Hematoma (1884)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in new (b)(6).Medical intervention was required to prevent further patient injury.Alung technologies, inc.Received a report that a patient experienced a hematoma at site of hemolung catheter insertion.Compression was used to stop bleeding.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.During hemolung therapy, two 102 critical cabinet oxygen errors occurred, hemolung therapy was able to continue through the errors by switching between controllers.These errors were caused by faulty oxygen sensors and/or high ambient room oxygen levels.The software behaved as expected by shutting down the pumps when the oxygen sensor is reading a high level.Aside from the oxygen sensor issues, no other unexpected alarms or critical errors occurred.No abnormalities were noted within the co2 removal and blood flow graphs.Hemolung therapy was provided as intended.A repair has since been implemented to resolve issues regarding oxygen sensor alarms.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.Hematoma is a known possible occurrence with extracorporeal 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.

Event Description

Alung technologies, inc.Received a report that a patient experienced a hematoma at site of hemolung catheter insertion.Compression was used to stop bleeding.

• 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: 16200035
• MDR Text Key: 307659202
• Report Number: 3009763347-2023-00062
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00850046004179
• UDI-Public: (01)00850046004179(17)210701
• 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
• Remedial Action: Repair
• 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: 07/01/2021
• Device Model Number: HL-CA10-00-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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