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	Anemia (1706)
Date of Event	03/04/2022
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.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Consistent blood flows and co2 removal were observed at the time of the event.The date log showed that two days following the event, the patient was re-cannulated and a new circuit was connected without issue.There were no abnormal user interactions identified in the data log on the reported event date.Therapy was provided as intended.No corrective action was identified for this event.Anemia is a known possible occurrence with extracorporeal hemolung therapy.Review of 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 review 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 that a patient experienced severe and acute anemia during support utilizing a hemolung ras controller.The anemia was managed through administering four units of prbcs during a 24-hour period.

• 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, INC; 2500 jane st.; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st.; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16435622
• Report Number: 3009763347-2023-00115
• Device Sequence Number: 15315894
• Product Code: QOH
• UDI-Device Identifier: 00850046004056
• UDI-Public: (01)00850046004056(11)180731
• 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: 07/31/2018
• 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