BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXBLEND2, 0-30 LPM

    MDR report key: 21859764 · Received April 17, 2025

    Report

    Report Number
    1000117260-2024-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    May 30, 2024
    Report Date
    December 16, 2024
    Manufacturer
    MAXTEC LLC
    Product Code
    BZR
    UDI-DI
    00853061006043
    PMA / PMN Number
    K973646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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."

    Description of Event or Problem · 0

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733274 MAXBLEND2, 0-30 LPM AIR-OXYGEN BLENDER BZR MAXTEC LLC MAXBLEND2, 0-30 LPM W/DISS LOW FLOW GC03833 00853061006043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other