BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3832852 · Received March 17, 2014

    Report

    Report Number
    3004531588-2014-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Report Date
    March 11, 2014
    Manufacturer
    IKARIA
    Product Code
    MRP
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL NON-SERIOUS CASE REPOT WAS RECEIVE ON (B)(6) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO CALLED TO SPEAK WITH IKARIA TECHNICAL SERVICES ABOUT A FAILED NO SENSOR ALARM FOLLOWING A DELIVERY FAILURE WITH THE INOMAX DSIR (B)(4) WHILE IN USE ON A PATIENT. THERE WAS NO IMPACT TO THE PATIENT. ((B)(4)). THE DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. EVALUATION SUMMARY: THE INOMAX DSIR DEVICE SERIAL NUMBER (B)(4) WAS RETURNED TO IKARIA'S REGIONAL SERVICE CENTER (RSC) FOR SERVICE EVALUATION. EXAMINATION OF THE SERVICE LOG CONFIRMS THE REPORTED COMPLAINTS OF DELIVERY FAILURE ALARM WHILE DELIVERY 16PPM NO WITH ACCEPTABLE INJECTOR MODULE FLOW AND FAILED NO CELL ALARMS. THE LOG ALSO REVEALS A FAILED LOW NO CALIBRATION WITH ELEVATED LOW POINT COUNTS ABOVE THE MAXIMUM ALLOWABLE COUNTS AND PRECEDING NO OF 62 PPM CONSISTENT WITH A FAILING NO CELL. THE FAILING NO CELL AS EVIDENCED BY THE FAILED LOW NO CALIBRATION WITH ELEVATED LOW POINT COUNTS COULD HAVE CONTRIBUTED TOT HE DELIVERY FAILURE ALARM. THE RSC INVESTIGATION EXPERIENCED BOTH THE DELIVER FAILURE AND FAILED NO SENSOR ALARMS, AND THE NO CELL WAS REPLACED. THE ZERO VALVE WAS ALSO REPLACED AS A PRECAUTION. THE ROOT CAUSE FOR THE INCIDENT WA NO CAL LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM.

    Description of Event or Problem · 1

    INOMAX DSIR WENT INTO DELIVERY FAILURE (DEVICE MALFUNCTION) FAILED NO SENSOR ALARM FOLLOWING A DELIVERY FAILURE (DEVICE MALFUNCTION). CASE DESCRIPTION: THIS INITIAL NON-SERIOUS DEVICE CASE REPORT WAS RECEIVED ON (B)(4) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO CALLED TO SPEAK WITH IKARIA TECHNICAL SERVICES ABOUT A FAILED NO (NITRIC OXIDE) SENSOR ALARM FOLLOWING A DELIVERY FAILURE WITH THE INOMAX DSIR (B)(4) WHILE IN USE ON A PATIENT. THERE WAS NO IMPACT TO THE PATIENT. IKARIA INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2014. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: NO PATIENT INFORMATION PROVIDED. RELEVANT CONCOMITANT MEDICATIONS: ALBUTEROL. THE PATIENT WAS STARTED ON AN UNDISCLOSED DATE VIA THE INOMAX DSIR (B)(4). THE DOSE OF INOMAX WAS NOT PROVIDED. THE RT REPORTED THAT ON (B)(6) 2014, "WHILE THE PATIENT WAS RECEIVING NEBULIZER ALBUTEROL TREATMENTS, THE BESIDE RT MOVED THE SAMPLE TEE AND GOT A DELIVERY FAILURE (ALARM) WITH THE INOMAX DSIR, BUT DID NOT NOTICE THE MONITOR VALUE REACH ABOVE 100 PPM". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH THE INOBLENDER WHILE THE INOMAX DSIR WAS POWERED OFF AND ON TO RESET THE DELIVERY FAILURE ALARM. UPON BOOT UP THE FAILED (NO) SENSOR ALARM APPEARED. THE BEDSIDE RT SWITCHED THE DEVICE OFF THE PATIENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ONCE OFF THE PATIENT, THE RT PERFORMED RECALIBRATIONS ON THE INOMAX DSIR (B)(4), BUT WAS UNABLE TO CLEAR THE FAILED SENSOR ALARM. THE DEVICE WAS RETURNED TO IKARIA FOR SERVICE EVALUATION. CASE COMMENT: (B)(6) 2014: THE CASE DID NOT RESULT IN AN ADVERSE EVENT, HOWEVER IT IS BEING REPORTED BECAUSE A SIMILAR FAILURE OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (SEE MDR#3004531588-2013-00022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156833 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRP IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 ALBUTEROL, (B)(4), (SALBUTAMOL)