BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 11144741 · Received January 10, 2021

    Report

    Report Number
    3004531588-2020-00185
    Event Type
    Injury
    Date Received
    January 10, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 10, 2021
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11-JAN-2021, THE DISTRIBUTOR REPORTED THAT THEY HAVE A GENERAL PRACTICE OF CLEANING INJECTOR MODULES BEFORE PERFORMING TESTING. THUS ONE POSSIBLE REASON THE DISTRIBUTOR WAS UNABLE TO REPLICATE THE INCIDENT IS THAT ANY DEBRIS THAT MAY HAVE BEEN ON THE INJECTOR MODULE'S HOT-FILM SENSOR MAY HAVE BEEN WASHED AWAY DURING THE CLEANING PRIOR TO TESTING THEREFORE ALLOWING THE INJECTOR MODULE TO FUNCTION NORMALLY DURING TESTING. (B)(4). (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS BEING REPORTED AS A MDR DUE TO THE PATIENT'S POSSIBLE LIFE THREATENING OXYGEN SATURATION LEVEL OF 40-60% DURING THE EVENT. THE DISTRIBUTOR MANAGES THE SERVICE HISTORY RECORDS FOR THIS DEVICE. THE DEVICE WAS RETURNED TO THE DISTRIBUTOR ALONG WITH TWO INJECTOR MODULES (S/N# (B)(4) AND (B)(4)) AND TWO INJECTOR MODULE CABLES. UPON VISUAL INSPECTION OF INJECTOR MODULE, 20034052, IT WAS FOUND THAT THIS INJECTOR MODULE WAS DAMAGED AS ITS TEMPERATURE FILAMENT WAS COMPLETELY CUT. HOWEVER, A REVIEW OF THE SERVICE LOG IDENTIFIED NO EVIDENCE THAT INJECTOR MODULE 20034052 WAS IN USE WITH INOMAX DSIR SERIAL # (B)(4) DURING THE REPORTED INCIDENT. THE DEVICE WAS TESTED USING INJECTOR MODULE, 21403131, FOR OVER THREE DAYS IN A ROW WITH SEVERAL/VARIANT SETTINGS AND THE ISSUE COULD NOT BE REPLICATED. THE DEVICE PERFORMED AS EXPECTED DURING TESTING. THE DEVICE'S SERVICE LOG WAS REVIEWED. THE SERVICE LOG CONFIRMED THE OCCURRENCE OF SEVERAL HIGH NO, LOW NO, AND DELIVERY FAILURE ALARMS AT THE TIME OF THE EVENT WITH INJECTOR MODULE, 2140313. THE SERVICE LOG INDICATED THAT THE DEVICE'S PROTECTION AGAINST FAULT OCCURRED AS EXPECTED AS SEVERAL DELIVERY FAILURE ALARMS OCCURRED FOR MONITORED NO > ABSOLUTE MAX OF 100 PPM FOR TWELVE CONSECUTIVE SECONDS. THE SERVICE LOG APPEARS TO SHOW THAT INJECTOR MODULE, 2140313, WAS POTENTIALLY OVER REPORTING THE MEASURED BREATHING CIRCUIT FLOW. WHILE WE COULD NOT REPLICATE THIS ISSUE DURING TESTING, A POTENTIAL ROOT CAUSE FOR AN INJECTOR MODULE OVER REPORTING THE MEASURED BREATHING CIRCUIT FLOW IS THAT THE NEBULIZED MEDICATIONS MAY HAVE COATED THE INJECTOR MODULE'S INTERNAL SENSORS. ANY DEBRIS BUILT UP ON THE INJECTOR MODULE'S HOT-FILM SENSOR AFTER CALIBRATION COULD POTENTIALLY AFFECT THE HEAT TRANSFER RATE AND/OR THE RESISTANCE OF THE HOT WIRE, WHICH COULD LEAD TO THE INJECTOR MODULE MEASURING EITHER HIGHER OR LOWER THAN THE ACTUAL FLOW DEPENDING ON THE DEBRIS EFFECT. THE ROOT CAUSE FOR THE HIGH NO - CONDITION, LOW NO - CONDITION, INJECTOR MODULE FAILURE AS WELL AS THE PATIENT'S MALAISE AND OXYGEN DESATURATION COULD NOT BE DETERMINED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, HIGH NO - CONDITION, LOW NO - CONDITION, INJECTOR MODULE FAILURE, MALAISE, AND OXYGEN DESATURATION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. ADVERSE EVENT TERMS: OXYGEN SATURATION, LOW AND MALAISE. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT INOMAX DSIR DEVICE DG20160031 SUDDENLY DISPLAYED INCREASED NITRIC OXIDE (NO) VALUES DURING THERAPY (DATE OF EVENT (B)(6) 2020 BY NIGHT). THE DISTRIBUTOR STATED THAT THE INOMAX DSIR NO DOSING WAS SET AT 10PPM NO WHILE THE MONITORING SHOWED 140PPM NO. THE DISTRIBUTOR REPORTED THAT THE CUSTOMER CHANGED ALL TUBINGS, THE INJECTOR MODULE, AND CALIBRATED THE DEVICE AGAIN BUT THE NO VALUES WERE STILL THE SAME. THE DISTRIBUTOR STATED THAT WHEN THE INOMAX DSIR DEVICE'S SAMPLE LINE WAS NOT CONNECTED TO THE PATIENT AND WAS MEASURING ROOM AIR, THE DEVICE MONITORED O2=21, NO2=0.0, NO= -0.3. ACCORDING TO THE DISTRIBUTOR, THE INOMAX DSIR DEVICE HAD BEEN IN THERAPY FOR A FEW DAYS. THE DISTRIBUTOR REPORTED THAT THE INCREASED NO VALUES SUDDENLY APPEARED AND THE PATIENT WAS NOT FEELING WELL. THE CUSTOMER WAS INFORMED BY THE DISTRIBUTOR ABOUT THE BACKUP POSSIBILITIES WITH THE INOMAX DSIR DEVICE. THE DISTRIBUTOR STATED THAT THE EXCHANGE OF THE INOMAX DSIR DEVICE WAS INITIATED BY THE DISTRIBUTOR'S TECH-SUPPORT. THE DISTRIBUTOR REPORTED THAT THEY SENT A THERAPY SPECIALIST TO VISIT THE CUSTOMER LATE ON (B)(6) 2020. THE THERAPY SPECIALIST STATED THAT THE MONITORED NO OF 100-140 PPM WAS NO LONGER PRESENT. THE THERAPY SPECIALIST REPORTED THAT WHEN THE INOMAX DSIR DEVICE WAS SET TO 20PPM NO, THE MEASURED READINGS WERE 24% O2, 0.0 NO2, AND 0.7 NO JUST BEFORE THE INOMAX DSIR DEVICE WAS EXCHANGED. THE THERAPY SPECIALIST STATED THAT THE INOMAX DSIR DEVICE'S INJECTOR MODULE HAD BEEN REPLACED TWICE AND THE INJECTOR MODULE CABLE/INJECTOR MODULE WAS REPLACED ONCE. THE THERAPY SPECIALIST REPORTED THAT THE REPLACEMENT INOMAX DSIR DEVICE WAS CALIBRATED DIRECTLY BEFORE USE (BOTH HIGH/LOW CALIBRATION WERE PERFORMED), AND THE PRE-USE CHECKOUT WAS PERFORMED AS WELL. THE THERAPY SPECIALIST STATED THAT IMMEDIATELY AFTER THE REPLACEMENT, THE INOMAX DSIR DEVICE DISPLAYED AN INJECTOR MODULE ERROR. THE THERAPY SPECIALIST REPORTED THAT THIS ERROR WAS STOPPED BY REPLACING THE INOMAX DSIR DEVICE'S INJECTOR MODULE WITH A NEW INJECTOR MODULE. THE THERAPY SPECIALIST STATED THAT THE REPLACEMENT INOMAX DSIR DEVICE RAN PERFECTLY. THE DISTRIBUTOR REPORTED THAT AT THE TIME OF THE EVENT THE PATIENT WAS ON A DRAEGER V300 VENTILATOR. THE DISTRIBUTOR STATED THAT THE PATIENT'S OXYGEN SATURATION WAS 60 - 80% BEFORE THE INCIDENT AND 40 - 60% DURING THE EVENT. THE DISTRIBUTOR REPORTED THAT THE DOCTOR ON DUTY AT THE TIME OF THE EVENT STATED THAT BOTH SALINE AND SALBUTAMOL WERE USED FOR NEBULIZATION FOR THIS PATIENT. THE DISTRIBUTOR STATED THAT ACCORDING TO THE DOCTOR THE NEBULIZED MEDICATION WAS INJECTED BEFORE THE NO READING WAS TAKEN BY THE INOMAX DSIR DEVICE. THE DISTRIBUTOR REPORTED THAT THE DOCTOR STATED THAT A DISC FILTER WAS NOT USED IN THE INOMAX DSIR DEVICE AT THE TIME OF THE EVENT. THE DISTRIBUTOR REPORTED THAT THE DOCTOR STATED, "HOWEVER, A DISC FILTER WILL BE USED FOR EVERY THERAPY IN THE FUTURE". THE DISTRIBUTOR STATED THAT ACCORDING TO THE DOCTOR, THE LITTLE PATIENT'S LUNGS ARE AND WERE SEVERELY HYPOPLASTIC. THE DISTRIBUTOR REPORTED THAT THE DOCTOR STATED THAT NO HAD IMPROVED THE PATIENT'S OXYGENATION. THE DISTRIBUTOR STATED THAT ACCORDING TO THE DOCTOR THE PATIENT IS CURRENTLY RELATIVELY STABLE AND IS NO LONGER RECEIVING NO. THE DISTRIBUTOR REPORTED THAT A FOLLOW-UP TRAINING FOR THIS CUSTOMER IS SCHEDULED FOR MID-(B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40932 INOMAX DSIR (DELIVERY SYSTEM) INOMAX DSIR MRN MALLINCKRODT MANUFACTURING LLC. 10071

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Life Threatening