BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6158128 · Received December 9, 2016

    Report

    Report Number
    3004531588-2016-00079
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 8, 2016
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS COMPLAINT-(B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 07-DEC-2016. SERVICE LOG REVIEW CONFIRMS THE SECOND-HAND REPORTED COMPLAINT OF SAMPLE LINE FILTER BLOCK ALARMS TWO DAYS INTO SEQUENCE 88B (STARTED (B)(6) 2016) CONSISTENT WITH THE REPORTED COMPLAINT DATE. THESE ALARMS ARE ALSO CONSISTENT WITH THE SECOND-HAND REPORTED LOUD SAMPLE PUMP. THE REVIEW DOES NOT CONFIRM THE REPORTED WATER BOTTLE FULL ALARMS IN SEQUENCE 88B, BUT DOES REVEAL A SINGLE INSTANCE OF THE ALARM IN SEQUENCE 78B ON (B)(6) 2016 INCONSISTENT WITH THE COMPLAINT DATE. THE REGIONAL SERVICE CENTER (RSC) SERVICE INVESTIGATION DID NOT CONFIRM ANY ALARMS AT BOOT UP, BUT DID REPORT A LOUD SAMPLE PUMP AND IDENTIFIED CONTAMINATION THROUGHOUT THE SAMPLE SYSTEM. THE RSC INVESTIGATION REPLACED THE WATER TRAP ASSEMBLY, SAMPLE GAS MANIFOLD, SAMPLE PUMP, ZERO VALVE, AND TUBING KIT. THE REPORTED COMPLAINT OF A WATER TRAP FULL ALARM IS UNRELATED TO THE CAUSE OF THE PATIENT DESATURATION. THIS ALARM DOES NOT CAUSE A WITHDRAWAL OF DRUG DELIVERY. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THE ROOT CAUSE FOR THIS REPORT CANNOT BE DETERMINED. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A RESPIRATORY THERAPIST (RT) FROM THE UNITED STATES CALLED MALLINCKRODT CUSTOMER CARE TO REPORT A DEVICE ISSUE WITH INOMAX DSIR (B)(4). THE RT CALLED TO SECOND HAND REPORT A DESATURATION ON (B)(6) 2016 WITH A (B)(6) YEAR OLD MALE PATIENT. THE PATIENT'S MEDICAL CONDITIONS INCLUDE MORBID OBESITY, RESPIRATORY FAILURE AND PULMONARY EDEMA. THEY WERE UNABLE TO SUPPLY A LIST OF CURRENT MEDICATIONS WHEN ASKED. ON (B)(6) 2016 THE PATIENT WAS STARTED ON INOMAX AT 20PPM WITH DSIR+ SERIAL NUMBER (B)(4). THE PATIENT WAS MECHANICALLY VENTILATED VIA A PURITAN BENNETT 840 IN VOLUME CONTROL WITH RESPIRATORY RATE OF 35, TIDAL VOLUME 380, PEEP 13, AND OXYGEN AT 100%. AT 23:30 THE DSIR WAS ALARMING WATER TRAP BOTTLE FULL AND NO MONITORED VALUES DISPLAYED AS THIS IS A MONITORING ISSUE. THE RT WAS NOTIFIED THAT A WATER TRAP BOTTLE ALARM DOES NOT INTERRUPT THE DELIVERY OF INOMAX. THEY REPORT THEY "WERE UNCERTAIN THAT PATIENT WAS GETTING PRESCRIBED DOSE". WATER SEPARATOR CARTRIDGE AND SAMPLE LINE REPLACED. THEY ALSO ATTEMPTED A LOW CALIBRATION AND IT WOULD NOT PERFORM. THIS DID NOT CORRECT THE ISSUE. THEY ALSO REPORTED A LOUD SAMPLE PUMP. IT WAS DECIDED TO SWITCH OUT THE DSIR+ SINCE THEY BELIEVED THEY WERE NOT ABLE TO ENSURE THE PROPER DELIVERY. AT THAT POINT THE SPO2 WAS NOT STABLE. THE REPORTED BASELINE OXYGEN SATURATION WAS 94% AND DECREASED TO 70%'S. THE PATIENT WAS MANUALLY VENTILATED WITH THE INOBLENDER AT 20PPM AND 100% OXYGEN. THE DESATURATION RETURNED TO BASELINE WITH MANUAL VENTILATION. INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813937 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other