MAUDE Adverse Event Report: MAXTEC, LLC MAXBLEND1; BLENDER

Model Number R203P05-001

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Summary: the maxblend is intended to provide a continuous air/oxygen gas mixture to infant, pediatric, and adult patients.The medwatch report received indicates that there is "no flow running through the bubble humidifier".The mixing of gasses does not impact the gas flow.The investigation involved interviews/communication, trend analysis, and historical data analysis.Through communication, the initial reporter provided a service report.The service report confirmed that the maxblend delivered mixed gas within specifications.The service report appeared to indicate that the failure occurred due to the flowmeter or o2 nipple.There are no trends related to the symptom described within maxtec's documentation.There are no trends related to the symptom reported in the maude database.The probable root cause is a failure of the facility's flowmeter or o2 nipple that was in use during the event.A corrective action plan has not been documented as the failure does not appear to be related to the maxblend.Maxtec's investigation: device detail: description: maxblend, lowflow air oxy diss fitting.P/n: r203p05-001.L/n: 021513.Serial number: (b)(4).Dom: 03/13/2006.The initial reporter confirmed that the unit is not available for evaluation on july 15, 2021.Additional information requested: how was the incident resolved? who is the manufacturer and which model of the flowmeter was used? was flow confirmed at the outlet of the flowmeter? could you provide a picture of the setup? the initial reporter was unable to answer the questions provided.The initial reporter was able to provide a service report completed by a third party.Third party service report invoice number (b)(4) details: the device in question was sent to a third party for servicing on august 5, 2020.The service report confirmed that the maxblend delivered mixed gasses within specification.The service report indicates that the problem occurred to due a o2 nipple leak or flowmeter failure.Maxtec's complaint database: a review of maxtec's complete available database was completed to identify any trends.No trends were identified as there were zero (0) similar complaints involving the maxblend.Key words to narrow down the search included "blender," "other," and blanks.Each description was reviewed for the symptom described such as "no flow" or "no gas." the complete complaint database for the key terms used was available from 07/30/2019 - 07/02/2021.Maude database: a review of the fda maude database was completed to identify any emerging trends similar to the symptom described.No trends were identified as there was only one (1) other related report.A total of 42 reports were identified using the following information: note: the 42 reports represent all reports submitted by end-users, facilities, importers, and manufacturers.The reports are not representative of events involving maxtec, llc.The reports are representative of the search terms that follow: product code: bzr, product class: mixer, breathing gases, anesthesia inhalation, date report received: 07/30/2019 - 07/02/2021.The summary of the reports is as follows: 40 reports are unrelated to the symptom described; 1 report, (b)(4), is the initial report submitted to the end user.This report is a response to report (b)(4).; 1 report, 2021710-2020-11822, involved a microblender that did not deliver o2 to the patient.The microblender is not a device manufactured by maxtec.The report states the following: root cause has not been determined: there was no patient harm.Report 2021710-2020-11822 cannot contribute to the event in question as the root cause is unknown.Device history record: the device history record is archived.The information is not necessary because the initial reporter provided sufficient information.Maxtec's capas, ncmrs, issues: a review of all capas, ncmrs, and issues launched between 07/30/2019 and 07/02/2021 was completed to identify similar symptoms.There were zero (0) capas, ncmrs, or issues launched due to the symptom or similar symptom described.Root cause: the root cause appears to be a flowmeter failure unrelated to the maxtec maxblend.Corrective action: maxtec is unable to outline corrective actions as the failure does not appear to be related to the maxblend.

Event Description

The description of the event as given to maxtec via medwatch 3500a report on 07/07/21: describe the event or problem: noted that the flow was set to 0.3-0.4 lpm with no flow running through the bubble humidifier.Readjusted the humidifier, increased the flow and only when it was greater than 0.5lpm did it show that flow was running through the humidifier.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: MAXBLEND1
• Type of Device: BLENDER
• Manufacturer (Section D): MAXTEC, LLC; 2305 s 1070 w; salt lake city UT 84119
• MDR Report Key: 12256570
• MDR Text Key: 265395953
• Report Number: 1000117260-2021-00007
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• PMA/PMN Number: K973646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R203P05-001
• Device Lot Number: 021513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2006
• 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 Age: 1 YR