BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2981109 · Received February 20, 2013

    Report

    Report Number
    2016493-2013-00113
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    RISK MANAGER REQUESTED A LOG REVIEW FOR AN OVERINFUSION OF TPN IN NICU. ON (B)(6) 2012, TPN WAS INFUSING AT 5.3 ML/HR FROM NOON TO 2245. BLOOD SUGAR AT 1550 WAS 62. AT 2245, A NEW BAG (APPROXIMATELY 225 ML IN A 500 ML BAG) WAS HUNG AND THE RATE WAS CHANGED TO 5.2 ML/HR. AT 2321, THE BLOOD SUGAR HAD RISEN TO GREATER THAN 600. AT 2330, THE TPN RATE WAS DECREASED TO 3 ML/HR AND A D5W INFUSION WAS ADDED AT 2.2 ML/HR. AT 0030 ON (B)(6) 2012, THE BABY WAS INTUBATED AND PLACED ON THE VENTILATOR. AT 0100, THE IV FLUIDS WERE DISCONTINUED AND THE NURSE NOTED THERE WAS ONLY 50 ML REMAINING IN THE TPN BAG. D10W WITH ADDITIVES WAS STARTED AND THE BLOOD SUGARS REMAINED ELEVATED FOR SEVERAL MORE HOURS. PATIENT EFFECTS RESOLVED WITHIN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72947 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNKNOWN| ALARIS SYRINGE MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| MODEL/LOT # UNKNOWN| ALARIS SYRINGE MODULE ADMINISTRATION SET: