BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3904980 · Received June 5, 2014

    Report

    Report Number
    2016493-2014-00276
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES RECEIVED. THE REPORTED INFUSION OF MGS04, WITH A CONCENTRATION OF 4 GRAM/100 ML, RUNNING AT 100 ML COULD NOT BE CONFIRMED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG FOR THE INFUSION IN QUESTION INDICATES THAT THERE WAS NO INFUSION OF MGS04, 4 GRAM/100 ML, RUNNING AT 100 ML/H WITH A VTBI AT 100 ML ON THE REPORTED DATE AND TIME PERIOD IN QUESTION. THE CONCENTRATION USED ON THE MGS04 INFUSION WAS PROGRAMMED AT 2 GRAM/50 ML AND THE RATE OF THE INFUSIONS WAS PERFORMED AT 50 ML/H. THE INFUSIONS BEING PERFORMED AT 500 ML/H MAY BE THE CAUSE FOR THE REPORTED INFUSION DISCREPANCY. THE DRUG CHOICE OF MGS04 IN THE CUSTOMER'S DATA SET FOR THE PROFILE OF PERINATAL FOR ALL LISTED CONCENTRATIONS HAS THE DEFAULT RATE OF 50 ML/H (DOSE=2 GRAM/H). THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS BEING ATTRIBUTED TO PROGRAMMING AND NOT THE RESULT OF A DEVICE MALFUNCTION. NO DEVICE MALFUNCTION IS BELIEVED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MGS04 4 GM/100 ML TO RUN AT 100 ML/H, DATED (B)(6) 2014, HUNG AT 0700 AS A PRIMARY INFUSION. STAFF DISCOVERED AROUND 0930 THERE WAS STILL FLUID REMAINING IN THE BAG (SHOULD HAVE BEEN COMPLETED AT 0800). THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330276 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| PUMP MODULE ADMIN SETS, MODEL/LOT # UNK