BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3953570 · Received July 8, 2014

    Report

    Report Number
    2523676-2014-00267
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 26, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS "A LEVOPHED DRIP WAS SET UP TO INFUSE AT 2MCG/KG/MIN. THE NURSE PROGRAMMED THE ORIGINAL INFUSION THROUGH THE DRUG LIBRARY AS NOREPINEPHRINE. THE PATIENT'S SYSTOLIC WAS 70 PRIOR TO INFUSION. ONCE THR DRIP WAS STARTED, THE PATIENT'S SYSTOLIC WENT TO 200. THE NURSE IMMEDIATELY STARTED TITRATING DOWN EVEN WHEN HE GOT TO 0.5MCG/KG/MIN IS STILL WAS CAUSING SEVERE HYPERTENSION. SO HE TURNED IT OFF THEN THE PATIENT'S BLOOD PRESSURE WENT RIGHT BACK DOWN TO THE 70'S SYSTOLIC. HE CALLED FOR A NEW BAG OF MEDS FROM PHARMACY AND DECIDED IN THE MEAN TIME TO CHANGE OUT THE PUMP AFTER SPEAKING TO THE DOCTOR. HE STARTED THE DRIP THE SAME WAY USING THE DRUG LIBRARY, A 2MCG/KG/MIN AND PATIENT RESPONDED APPROPRIATELY. THE NURSE CONTINUED TO INVESTIGATE WHAT HAPPENED THEN HE NOTICED THE RATE WAS 3.7ML/HR ON THE NEW PUMP. WE WENT BACK TO THE OLD PUMP WHICH WAS STILL SET AT 0.5MCG/KG/MIN AND HUNG A NORMAL SALINE ON IT. THE PUMP WAS RUNNING AT 46.87ML/HR. THE PUMP WAS TAGGED AND GIVEN TO BIOMED." BIOMED ATTEMPTED TO REPLICATE THE INCIDENT AND FOUND THAT MIGHT HAVE BEEN PROGRAMMED AT 25MCG/KG/MIN. BIOMED WAS ALSO UNABLE TO PULL THE HISTORY FROM THAT DATE. INCIDENT DATE: (B)(6) 2014 NO PATIENT INJURY. MFR REPORT #: 9610825-2014-00267.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397327 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK