BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 14326089 · Received May 7, 2022

    Report

    Report Number
    3004531588-2022-00057
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    UDI-DI
    00867538000106
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS REPORTABLE AS A MDR DUE TO THE MEDICAL INTERVENTION OF THE INCREASE IN NOREPINEPHRINE THAT WAS PROVIDED TO THE PATIENT. THE INOMAX DSIR PLUS DEVICE, (B)(4), WAS RETURNED TO THE REGIONAL SERVICE CENTER (RSC) FOR INVESTIGATION. THE RSC ALSO EXPERIENCED THE REPORTED COMPLAINT OF LOW NO DURING TESTING. DURING NO DELIVERY TESTING, THE DEVICE MONITORED LOW NO VALUES WHILE AT A DELIVERY SET POINT OF 40PPM (0.6PPM NO @40PPM), 20PPM (0.6PPM NO @20PPM) AND BACKUP (0.7PPM NO @BACKUP). THE RSC PERFORMED A HIGH NO CELL CALIBRATION WHICH FAILED. DURING THE HIGH NO CALIBRATION, THE DEVICE MONITORED NEGATIVE NO VALUES. THE RSC REPLACED THE NO CELL. AFTER NO SENSOR REPLACEMENT, THE DEVICE SUCCESSFULLY PASSED HIGH NO CALIBRATION AND THE DEVICE MONITORED WITHIN SPECIFICATION AT ALL DELIVERY SET POINTS. ALTHOUGH IDENTIFIED IN THE DEVICE'S SERVICE LOG, THE RSC DID NOT EXPERIENCE AN INJECTOR MODULE FAILURE ALARM DURING TESTING WITH THE CUSTOMER'S RETURNED INJECTOR MODULE. THE SERVICE LOG AND INVESTIGATION DID NOT UNCOVER ANY DELIVERY SYSTEM ISSUE WITH THE DEVICE AND THE DEVICE DID NOT WITHDRAW NO DRUG FLOW FROM THE PATIENT. THE INVESTIGATION CONFIRMED ONLY A MALFUNCTIONING NO MONITORING SENSOR. DUE TO THE DEVICE'S DUAL CHANNEL DESIGN WHERE NO DELIVERY IS INDEPENDENT OF MONITORING, THE DEVICE DID NOT INTERRUPT NO DRUG DELIVERY DUE TO A MALFUNCTIONING NO MONITORING SENSOR. HOWEVER, SUBSEQUENT LOG ENTRIES DID CONFIRM CUSTOMER INTERVENTIONS THAT COULD HAVE RESULTED IN THE INTERRUPTION OF NO DRUG FLOW TO THE PATIENT. SPECIFICALLY, WHEN THE CUSTOMER BRIEFLY SET THE PATIENT'S NO DOSE TO ZERO AND WHEN THE CUSTOMER LIKELY DISCONNECTED THE DEVICE'S REGULATOR HOSE. ALL OF THESE INTERVENTIONS ARE NOT PROPER TROUBLESHOOTING STEPS AS PER THE OPERATOR'S MANUAL. THE ROOT CAUSE FOR THE DEVICE'S LOW NO - ALARM WAS A NO CELL FAILURE. THE ROOT CAUSE FOR THE DEVICE'S INJECTOR MODULE FAILURE ALARM COULD NOT BE DETERMINED AS IT WAS NOT REPRODUCIBLE DURING THE DEVICE'S INVESTIGATION. THE ROOT CAUSE FOR THE PATIENT'S HYPOTENSION WAS MOST LIKELY DUE TO USE ERROR AS A RESULT OF THE CUSTOMER'S IMPROPER TROUBLESHOOTING ACTIONS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, INJECTOR MODULE FAILURE, LOW NO - ALARM, AND HYPOTENSION. 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: LOW BLOOD PRESSURE / HYPOTENSION. (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION WHILE ON THE INOMAX DSIR PLUS DEVICE. THE CUSTOMER STATED THAT THE PATIENT WAS RECEIVING INOMAX THERAPY DUE TO A MASSIVE PULMONARY EMBOLISM AND RIGHT HEART STRAIN. THE CUSTOMER REPORTED THAT THE PATIENT WAS RECEIVING PROPOFOL, VASOPRESSIN, AND NOREPINEPHRINE ALONG WITH INOMAX AT 20PPM NITRIC OXIDE (NO). THE CUSTOMER STATED THAT THE PATIENT WAS BEING VENTILATED WITH A MAQUET SERVO U VENTILATOR AT THE FOLLOWING SETTINGS: VC 450 RR 24, PEEP 5CM H2O, PRESSURE SUPPORT 0, AND FIO2 40%. THE CUSTOMER REPORTED THAT THE PATIENT'S BASELINE OXYGEN SATURATION WAS 100%. THE CUSTOMER STATED THAT THE INOMAX DSIR PLUS DEVICE HAD PASSED A PRE USE CHECK WITHOUT ISSUE AND WAS SET UP TO DELIVER 20PPM OF NITRIC OXIDE (NO) TO THE PATIENT. THE CUSTOMER REPORTED THAT HE WAS CALLED TO THE PATIENT'S BEDSIDE APPROXIMATELY AN HOUR LATER DUE TO THE INOMAX DSIR PLUS DEVICE ALARMING LOW NO WITH A READING OF 0.6PPM. THE CUSTOMER REPORTED THAT HE REVIEWED THE CIRCUIT SETUP, AND ALL APPEARED CORRECT. THE CUSTOMER STATED THAT HE PERFORMED A LOW NO CALIBRATION AND THE INOMAX DSIR PLUS DEVICE PASSED WITHOUT ANY ISSUE, BUT THEN THE INOMAX DSIR PLUS DEVICE ALARMED INJECTOR MODULE FAILURE. THE CUSTOMER REPORTED THAT THE DEVICE'S INJECTOR MODULE AND CABLE WERE THEN SWAPPED OUT WITH A SPARE; HOWEVER, THE CUSTOMER DID NOT FEEL THAT THIS ACTION CORRECTED THIS ISSUE. THE CUSTOMER STATED THAT DURING THIS EVENT, HE NOTICED A DROP IN THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) FROM THE TARGETED MAP OF 60-70 MM HG DOWN TO 43 MM HG. THE CUSTOMER REPORTED THAT HE THEN ACTIVATED THE INOMAX DSIR PLUS DEVICE'S BACK UP MODE BY ACTIVATING ITS INTEGRATED PNEUMATIC BACK UP SWITCH. THE CUSTOMER STATED THAT HE WAS NOW CONFIDENT THAT THE INOMAX DSIR PLUS DEVICE WAS DELIVERING THE APPROPRIATE NO DOSE TO THE PATIENT AND DID NOT FEEL THAT IT WAS NECESSARY TO USE THE INOMAX DSIR PLUS DEVICE'S INOBLENDER OR GIVE THE PATIENT MANUAL RESUSCITATION. THE CUSTOMER REPORTED THAT DUE TO THE PATIENT'S DECREASE IN MAP, THE NURSE TITRATED THE PATIENT'S NOREPINEPHRINE FROM 40 MCG/MIN TO 60 MCG/MIN. THE CUSTOMER STATED THAT THE PATIENT RETURNED TO BASELINE WITHIN TEN MINUTES. THE CUSTOMER REPORTED THAT DURING THIS EVENT, HE DID NOT FEEL THE NEED TO INCREASE THE VENTILATOR'S FIO2 AS THE PATIENT'S OXYGEN SATURATION REMAINED UNCHANGED AT 100%. THE CUSTOMER STATED THAT THE PATIENT'S RESPIRATORY RATE ALSO REMAINED UNCHANGED. THE CUSTOMER REPORTED THAT THERE WAS NO CHANGE IN THE PATIENT'S HEARTRATE OR OTHER VITAL SIGNS. THE CUSTOMER STATED THAT THE INOMAX DSIR PLUS DEVICE WAS SWAPPED FOR A BACKUP INOMAX DSIR PLUS DEVICE WHICH OPERATED NORMALLY. THE CUSTOMER STATED THAT HE PERFORMED MULTIPLE TROUBLESHOOTING ACTIVITIES ON THE INOMAX DSIR PLUS DEVICE ONCE IT WAS REMOVED FROM THE PATIENT. THE CUSTOMER REPORTED THAT HE DID NOT FIND ANY ERRORS OR ISSUES WITH THE DEVICE DURING HIS TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375834 INOMAX DSIR PLUS (DELIVERY SYSTEM) INOMAX DSIR PLUS MRN MALLINCKRODT MANUFACTURING LLC. 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention