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

Model Number	21000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras.The incident occurred in minneapolis, minnesota.Medical intervention was required to prevent further patient injury.There is no alleged device malfunction which occurred in relation to the reported patient adverse event.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Hemolung therapy was provided as intended.No corrective action was initiated in response to this event.Cardiac arrhythmia is a known potential complication associated with use of extracorporeal therapy and critical illness (patient suffered from covid-19 and respiratory acidosis).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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Data log reviewed.
Event or Problem Description
Alung technologies, inc.Received a report of a patient who experienced a cardiac arrhythmia during support with a hemolung ras controller.The cardiac arrhythmia required one or more medical interventions in order to prevent permanent injury.

• Brand Name: HEMOLUNG RAS
• Common Device Name: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane st; suite 1; pittsburgh PA 15203
• Manufacturer (Section G): ALUNG TECHNOLOGIES; 2500 jane st; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16440352
• Report Number: 3009763347-2023-00116
• Device Sequence Number: 3136174
• Product Code: QOH
• UDI-Device Identifier: 00850046004056
• UDI-Public: (01)00850046004056(11)171130
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: DEN210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 21000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown