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

Model Number HL-CA09-00-000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/25/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4).Alung technologies, inc.Received a report that post hemolung catheter removal, blood loss occurred resulting in need for transfusion.Per protocol, heparin drip was stopped for 2 hours prior to removal of the catheter.Site was cleaned with antiseptic, sutures were removed, and the catheter removed without any difficulty.Pressure was held at the site for 5 minutes.Afterwards, the pressure was released and site confirmed no bleeding.A clean dressing was then applied.Approximately 5 minutes later, the patient was noted to have brisk bleeding from the site that soaked the bed sheets.Pressure was again held at the site and iv fluids started.A new dressing was placed after hemostasis was achieved.A sandbag was placed on the site.The patient was to receive one unit of blood and monitor hemodynamics and hgb.The patient was awake and alert with no specific problems verbalized.Heparin drip remained on hold.Event resolved same day.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.There were no unexpected alarms and no critical errors.Therapy was provided as intended.No capa was opened because of this event.Bleeding is a known possible complication associated with anticoagulation of extracorporeal therapy.Examination of the controller data log shows that 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 of a patient experiencing bleeding at the catheter site after hemolung therapy ended and the catheter was removed per protocol.Medical intervention was required by applying pressure to the site, starting iv fluids, and placing a new dressing and sandbag on the site.The patient required transfusion of one unit of blood.Therapy had been provided as intended.

• 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: 16211956
• MDR Text Key: 307764960
• Report Number: 3009763347-2023-00098
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00850046004162
• UDI-Public: (01)00850046004162(17)210702
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: HL-CA09-00-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: No
• 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