BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET,

    MDR report key: 3222005 · Received July 3, 2013

    Report

    Report Number
    9616066-2013-00503
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    A SECOND FLOOR ICU PT WAS RECEIVING SECONDARY INFUSION OF POTASSIUM CHLORIDE. THE RN EXPECTED THE INFUSION TO RUN OVER TWO HRS HOWEVER THE BAG WAS EMPTY IN MINUTES. THE CLINICAL MGR WAS CONTACTED WHO ATTACHED A 100 ML NORMAL SALINE BAG TO SECONDARY LINE AND OBSERVED PRIMARY BAG BECOMING FULLER. THE PUMP WAS CHANGED WITH SAME RESULT. THE PRIMARY AND SECONDARY SET WERE CHANGED WITH INITIAL PUMP RUNNING AND INFUSION PROCEEDED WITHOUT PROBLEMS. THE PRIMARY INFUSION WAS D5 1/2 NORMAL SALINE TO RUN AT 100 ML/HR. THE SECONDARY INFUSION WAS POTASSIUM CHLORIDE 20 MEQ IN 100 ML TO RUN AT 50 ML/HR. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION OCCURRED. THE CUSTOMER STATED THAT THE USER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304666 ALARIS PUMP MODULE ADMINISTRATION SET, FPA CAREFUSION CORP 11607704 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| SECONDARY SET: MFR, MODEL AND LOT # UNK| ALARIS PUMP MODULE: SN UNK