MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Date 09/03/2017

Event Type  Injury  

Event Description

Alung technologies, inc.Received a report of a patient experiencing ventilator associated pneumonia during hemolung therapy.Therapy had been provided as intended.No further information was provided.

Manufacturer Narrative

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 london, united kingdom.Through review of the final clinical study adverse event listings, it was reported that a patient experienced ventilator associated pneumonia.As no further notification was received regarding this adverse event, no further information is available.No capa was opened because of this event.Infection, such as ventilator associated pneumonia, is a known complication of mechanical ventilation and has no relation to extracorporeal therapy.As this was reported through ae reporting and coded as related it was investigated through the complaint process.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
• 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: 16179748
• MDR Text Key: 307471210
• Report Number: 3009763347-2023-00013
• Device Sequence Number: 1
• Product Code: QOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: DEN120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other