MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19

Model Number HL-CR4-01-000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2020

Event Type  Injury  

Event Description

Alung technologies, inc.Received a report that medical staff had difficulty removing priming adapter during use of a hemolung catheter, the circuit clotted due to delay in catheter placement.Instances of user error were reported within hemolung therapy.There was no report of patient injury because of this issue.

Manufacturer Narrative

Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in houston, texas.During emergency use hemolung therapy, it was reported that site staff experienced a clotted circuit/cartridge.The physician had difficulty removing the priming adaptor from the catheter, which caused a delay to the pump starting.While troubleshooting the priming adaptor, one of the site staff's gowns inadvertently selected buttons on the touch screen of the controller.Clinical support was provided to recover the settings on the controller and resume the initiation of hemolung therapy.Once started, low blood flow was obtained, but manipulation of the catheter/patient positioning did not increase the flow.The physician decided to attempt to cut the circuit and flush both lumen, but while the pump was off during this process (approximately 3 minutes), blood appeared to have clotted within the circuit and the pump would not start again.The same circuit was placed onto a backup hemolung controller to rule out any issues with the controller, but the backup controller was also alarming for the clotted circuit.This circuit was unable to be used and had to be discarded.Clinical support was provided to the physician in which follow up discussion focused on how to avoid these issues with future catheters.The cartridge/circuit was not returned due to patient's covid-19+ status report.No reports were received of device malfunctions or clinical complications resulting from indications that the device consumables would have malfunctioned.Circuit clotting is known to possibly occur when the pump is stopped for a period of time.This was not an unexpected issue.No clinical complications were reported as to have occurred as a result of this issue.No capa was opened because of this event.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: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19
• 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: 16200034
• MDR Text Key: 307659255
• Report Number: 3009763347-2023-00061
• Device Sequence Number: 1
• Product Code: QLN
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)180827
• 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 Model Number: HL-CR4-01-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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): Other