MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG CATHETER KIT

Model Number REF 30100

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

Patient Problems Death (1802); Multiple Organ Failure (3261)

Event Date 02/17/2017

Event Type  Death  

Event Description

This is a result of the fda 483 file number (b)(4) - observation 1 - this incident occured after the final report so is in response to the action plan taken.The summary of the event is as follows: further information provided by the treating physician supports the initial conclusion that the hemolung ras did not contribute to the death of the described patient.The hemolung controller used in this case was thoroughly investigated by alung, subsequent to the report.In reviewing the data log from the controller, it was observed that an alarm occurred at the time of pump stoppage which was concurrent with a weakened state of the batteries.The batteries were evaluated and found to be within allowable range for operation; however, the weakened state may have allowed for the voltage signal to be out of range.The controller responded to this condition as intended - it recognized the condition, generated the appropriate alarm, and as programmed for this condition, stopped the pump.Conclusion: the hemolung ras provides partial, not full, lung support.It is not intended to, or capable of, providing full life support.At the time of hemolung therapy cessation, the patient was receiving life support via endotracheal intubation and invasive mechanical ventilation.As reported by the treating physician, the patient was critically ill with poor prognosis of survival at the time of therapy cessation.The physician reported and confirmed that cessation of hemolung therapy did not contribute to the patient's death.The cause of death is listed as multi-organ failure and withdrawal of treatments.The controller used during this case was found to have functioned as intended.In the abundance of caution, this controller has been serviced; oxygen sensors and batteries were replaced and tested to certify expected function.The device also received its annual preventative maintenance and calibration testing.This report was submitted to (b)(6) but at the point the closure letter has not been received by (b)(6).

• Brand Name: HEMOLUNG CATHETER KIT
• Type of Device: HEMOLUNG CATHETER KIT
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer (Section G): ALUNG TECHNOLOGIES; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer Contact: frank falcione ; 2500 jane street; suite 1; pittsburgh, PA 15203 ; 4126973370
• MDR Report Key: 6602781
• MDR Text Key: 76373131
• Report Number: 3009763347-2017-00009
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: REF 30100
• Device Catalogue Number: REF 30100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 61 YR