MAUDE Adverse Event Report: MAXTEC LLC MAXBLEND2, 0-30 LPM; AIR-OXYGEN BLENDER

Model Number	MAXBLEND2, 0-30 LPM W/DISS LOW FLOW
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 30th may 2024, maxtec llc received an email from (b)(6) of (b)(6).Below is his write up in quotations, we have received no further information from the complainant even after multiple follow ups.Other than them mentioning it is a maxtec blender, we are not aware of the particular device in question.No further investigation could take place as a result."gc03833005 please review blender blender stopped working while on an ecmo patient.Sweep was set at 2 lpm and a pre and post was conducted at the beginning of the shift yielding good results.3 hours later patient began to de-sat with the same settings.Blender was increased to 5 lpm to yield a avo2 difference.There was no connection alarm.The gas line was removed to confirm adequate gas flow.The connections were tight with no gas leakage.".
Additional Manufacturer Narrative
Assessment of risk: it was reported that the patient had desaturation.The end user was contacted multiple times with no response and no further information could be procured.Maxtec requested the device for further investigation and the device was not returned.Since maxtec could not confirm the device involved, a risk assessment cannot be provided at this time for the unknown blender.Device detail: description: blender p/n: unknown l/n: unknown dom: unknown (b)(4).Complaint/maude database review: a review of maxtec's complaint files and the maude database did not result in a significant review since it could not be confirmed that maxtec manufactured the device in question.Maxtec was unable to obtain any details about the blender such as part number, serial number, or model.Root cause: the most probable root cause is unknown at this time since maxtec was unable to evaluate the product, confirm the device, or receive any additional information from the end user.Corrective actions: there is no corrective action identified as the root cause is unknown.
Additional Manufacturer Narrative
Investigation activities: symptom described in the complaint: "patient began to desaturate" description: maxblend2, 0-30 lpm w/diss low flow, p/n: r229p01-001 · l/n: gc03833 · serial number: (b)(6).Dom: 5/10/2021.Containment activities: a review of in-house inventory indicated that there was no additional product on hand of this assembly lot (job) number.Our process requires each blender undergo 100% functional testing prior to release.Review of dhr records showed that the blender passed functional testing, however, the 'flow accuracy (mid)' has an out of specification figure recorded.The acc.Range is 2.5 - 3.5 lpm; the recorded reading was 3.6.Note: the recorded figures for both the 'flow accuracy (low)' and 'flow accuracy (high)' were within specification.Investigation determined that the variance in the flow accuracy (mid)' testing record did not contribute to this event.According to the complaint description, the blender was in a steady state of gas delivery and did not occur as a result of an adjustment to the flowmeter or inherent flowmeter inaccuracy.In this event even if there was some inaccuracy at these readings the slightly higher flow would not have caused a desaturation.If anything, a higher flow would lead to more oxygenation of the blood.Assessment of risk: it was reported that the patient had desaturation.The end user was contacted multiple times with no response and no further information could be procured.Maxtec requested the device for further investigation and the device was not returned.The maxblend2 is designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients.It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.E., hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required.This is not intended as a life supporting device.Inaccurate oxygen levels and inaccurate air flow readings are recognized risks identified by maxtec per dcd-0049 rev 05 hazard analysis, maxblend family.Current design controls and testing mitigate the risk as far as possible.Risk level is med (moderate risk - product is inoperable or resulted in system partial malfunction in use).Overall risk score of 6 (severity: 3 serious: results in temporary injury or impairment requiring professional medical intervention; occurrence: 2 remote: less than 1x per year).Complaint/maude database review: a review of maxtec's complaint files and the maude database did not result in a significant review.Root cause: the root cause is unknown.Additional information about the device's malfunction, system set up and patient injury was not provided.The device was not returned for further investigation.Corrective actions: capa-0090 has been initiated to further address the root cause of maxblend2 products with incomplete or incorrect testing documentation.Corrective actions to be implemented per the capa plan.
Event or Problem Description
On 30th may 2024, maxtec llc received an email from (b)(6) of (b)(6) health care.Below is his write up in quotations, we have received no further information from the complainant even after multiple follow ups.Other than them mentioning it is a maxtec blender, we are not aware of the particular device in question.No further investigation could take place by the time of initial report as a result of this lack of communication.We are submitting this update report after investigation is complete on our end."gc03833005.Please review blender.Blender stopped working while on an ecmo patient.Sweep was set at 2 lpm and a pre and post was conducted at the beginning of the shift yielding good results.3 hours later patient began to de-sat with the same settings.Blender was increased to 5 lpm to yield a avo2 difference.There was no connection alarm.The gas line was removed to confirm adequate gas flow.The connections were tight with no gas leakage.".

• Brand Name: MAXBLEND2, 0-30 LPM
• Common Device Name: AIR-OXYGEN BLENDER
• Manufacturer (Section D): MAXTEC LLC; 2305 s 1070 w; west valley city UT 84119
• Manufacturer (Section G): MAXTEC LLC; 2305 s 1070 w; west valley city UT 84119
• Manufacturer Contact: sri divya kadiyala ; 2305 s 1070 w; west valley city, UT 84119 ; 3855498070
• MDR Report Key: 21859764
• Report Number: 1000117260-2024-00001
• Device Sequence Number: 17317458
• Product Code: BZR
• UDI-Device Identifier: 00853061006043
• UDI-Public: 00853061006043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MAXBLEND2, 0-30 LPM W/DISS LOW FLOW
• Device Catalogue Number: R229P01-001
• Device Lot Number: GC03833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown