MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX OXYGEN FLOWMETER

Model Number FM-15UO-PB

Device Problems Detachment Of Device Component (1104); Excess Flow or Over-Infusion (1311)

Patient Problem Death (1802)

Event Date 01/29/2018

Event Type  Death  

Manufacturer Narrative

Medwatch report was received via email on tuesday feb 6, 2018, with an incorrectly identified serial number.User facility was asked to provide a picture of serial label to adequately review manufacturing history of the device.The user facility medwatch report has no identification number, therefore it will be attached to this manufacturer's report for reference.Manufacturing records were reviewed and no anomalies were noted, product met all release specifications, and was shipped on february 22, 2016.Engineering tests performed by ohio medical on multiple flow levels were not able to replicate this failure without occluding tubing and causing back pressure.Ohio medical contacted our clinical advisor regarding the incident, providing him with the user facility report and pictures that were provided of the device set up.He stated that "everyone should know that the flowmeter can provide more flow than the 15 lpm if flushed or you continue to open the needle valve once the thorpe tube reads 15 lpm.Flows higher than 15 lpm may cause tubing connections to that venturi device to pop off if not seated very well on both nipple adapters." it was also stated that he had never seen that type of setup and that there are more safe options that would provide less back pressure, which would prevent the tubing from popping off.He stated by looking at the picture that it is possible that the tubing was not properly seated on the flowmeter adapter.At this point, ohio medical believes that the flowmeter was working as intended.

Event Description

Ohio medical llc received a call on feb 2, 2018 regarding an incident that happened at (b)(6) hospital in (b)(6), usa which the user facility intended to report via medwatch.Information provided over the phone was minimal, however in summary, it was stated that an oxygen flowmeter was being used in connection with a humidifier, for purpose of a tracheostomy.The patient had just been transferred from a ventilator, and was placed on hospice status.The patient was left in the room and when staff and her husband returned, the tubing had popped off at the flowmeter adapter, and the t-piece was left on the patients chest.It was also stated that flowmeter was set to 15lpm, but was delivering 20lpm.It was suspected by the user facility that this is what caused the tubing to pop off, however this model of flowmeter has a visual thorpe scale up to 15lpm, but will provide more flow if needle valve is opened more (user turns flowmeter knob up more) with the possibility of delivering up to 50lpm.This is intentional, for the purpose of emergency resuscitation.During original, and subsequent conversations (verbal and via email) with original reporter return of flowmeter in question was requested by ohio medical, however, user facility has refused to provide return for evaluation.

Manufacturer Narrative

Original report submitted on feb 2, 2018 was incorrectly identified as a 5 day initial report versus a 30 day initial report.

Event Description

This is a correction to original report submitted on february 9, 2018.

Manufacturer Narrative

User facility was not able to present preventive maintenance records, or method of verification of tubing prior to use.Ohio medical believes that the flowmeter was working as intended, and advised the user facility that perhaps tubing was over-used, or improperly seated onto connector.

Event Description

This is a follow up to original report submitted on february 9, 2018, explaining results of investigation conducted at user facility by ohio medical representative on march 23, 2018.Setup that was being used at the time of event was duplicated, using original flowmeter, however all other components were new.Ohio medical rep questioned why entire original set up could not be evaluated and it was stated that original tubing had become "stretched" after use.Flowmeter was set at highest flow (flood) and allowed to continuously run (representing original event).This setup was observed from 9:25am until 10:25am and failure did not recur.All connections remained intact.Setup was then changed to allow direct source pressure to the flowmeter.This method was observed from 10:25am un til 11:05am and again, failure did not recur and all connections remained intact.Flowmeter accuracy was verified, and no failures were noted.While set to 'flood' flowmeter was delivering approximately 20lpm as intended.Sourcing information was requested for the tubing used, to determine if tubing was purchased from ohio medical, it was stated by user facility that the tubing was purchased by (b)(4).

• Brand Name: AMVEX OXYGEN FLOWMETER
• Type of Device: OXYGEN 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: 7262008
• MDR Text Key: 99824110
• Report Number: 1419185-2018-00001
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FM-15UO-PB
• Device Catalogue Number: FM-15UO-PB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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
• Patient Age: 69 YR
• Patient Weight: 52