BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4836051 · Received June 10, 2015

    Report

    Report Number
    2016493-2015-00441
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    May 28, 2014
    Report Date
    May 18, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER 'S (B)(4) REPORT STATES "PATIENT WAS ADMITTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) . THREE DAYS LATER, THE PATIENT WAS ON AMIODARONE, HEPARIN AND NOREPINEPHRINE DRIPS. DURING THE NIGHT SHIFT. THE NURSE ON DUTY HAD TO TITRATE NOREPINEPHRINE (CONCENTRATION 8MG/250 ML) FROM 0.06MCG/KG/MIN , TO 0.07 ONE HOUR LATER, TO 0.08 SEVEN HOURS LATER. BP HAD BEEN MAINTAINED APPROXIMATELY 88/68 BY ARTERIAL LINE, 90/63 BY CUFF UNTIL THE END OF TITRATION. SEVERAL HOURS LATER, THE PT WAS ON 0.4MCG/KG/MIN AND BP 205/123 BY ART LINE, 182/133 BY CUFF. AN HOUR LATER THE CONCENTRATION OF NOREPINEPHRINE WAS CHANGED TO 32 MG/500 ML AND DOSE WAS AT 0.4 MCG/KG/MIN. BP CONTINUED TO BE 161/102 BY ART LINE, CUFF PRESSURE 111/26. WITHIN 10 MINUTES, THE NOREPINEPHRINE WAS WEANED TO 0.2 MCG/KG/MIN. THE DOCTOR EXPRESSED CONCERN AS PATIENT WAS REPORTED AS BEING ON .08MCG BUT FOUND THE UMP AT 0.8 MCG. WHILE THEY WERE TROUBLESHOOTING THE RESPIRATORY THERAPIST CAME IN TO ASSESS ARTERIAL LINE AND AFTER LEVELLING AND ZEROING BP WAS FOUND TO BE SO ELEVATED. THE PUMP WAS REPROGRAMMED TO INITIAL MEDICATION CALCULATED WEIGHT FROM ICU. THE PUMP WAS TAKEN OUT OF PATIENT ROOM AT WHICH TIME THIS EVENT IS REPORTED. PUMP "BRAIN" CE 76034, NOREPINEPHRINE CHANNEL CE70420."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378822 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other