MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX INTEGRATED FLOWMETER

Model Number FI-T15UO-DN-E

Device Problem Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Date 01/20/2019

Event Type  Death  

Manufacturer Narrative

Ohio medical has been in continuous contact with the user facility and are awaiting final results of their investigation into this incident.As part of their internal investigation, ohio medical has also consulted with a 3rd party clinical consultant, who currently serves as department chair of cardiopulmonary and respiratory care program director at (b)(6) medical center, and it is strongly believed that, since the device was never observed having a "no flow" failure or lack of oxygen flow this device did not cause or contribute to the patient death.Additional information will continue to be gathered, as ohio medical is waiting on confirmation from the user facility that ifus and preventive maintenance protocols were followed.Subsequent follow up reports will be submitted to the fda in a timely manner.

Event Description

On january 22, 2019 ohio medical received report of an incident involving an alleged failure that the integrated flowmeter was not performing to specification during a patient code event.Device was returned to ohio medical for evaluation on february 5, 2019.Evaluation results shown below: no visual defects observed (i.E.No cracks, no visible damage).Unit was tested for supply side leak, no leaks observed.Unit was tested for patient side leak, no leaks observed.Unit set to 1lpm, unit reading was 1.4lpm.Unit was set to 3lpm, unit reading was 3.3lpm.Unit was set to 5lpm, unit reading was 5.9lpm.Unit was set to 10lpm, unit reading was 11.6lpm.Unit set to 15lpm, unit reading was 18.4lpm.When flow control knob was fully turned clockwise to set to maximum flow it was observed that the flow would increase and then lower and stabilize at 12.2lpm.The ohio medical test results conclude that while flow accuracy did not perform to specification oxygen flow was always being delivered and was in excess of the flow setting, except for when maximum flow rate was desired.At the maximum flow rate setting the unit would increase and then lower and stabilize at 12.2lpm.

• Brand Name: AMVEX INTEGRATED FLOWMETER
• Type of Device: INTEGRATED FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031 ; 8478556318
• MDR Report Key: 8364558
• MDR Text Key: 136977570
• Report Number: 1419185-2019-00001
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FI-T15UO-DN-E
• Device Catalogue Number: FI-T15UO-DN-E
• Device Lot Number: 0758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death