BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1172688 · Received September 10, 2008

    Report

    Report Number
    9616066-2008-00029
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCT
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDERINFUSION OF POTASSIUM. AN INFUSION OF POTASSIUM 20 MEQ IN 100 ML AT 50 ML/HR, VTBI 50 ML, WAS STARTED, PIGGYBACKED INTO THE PRIMARY LINE. AFTER 1 HOUR, THE NURSE RETURNED AND NOTED THE BAG OF POTASSIUM WAS EMPTY, THE DRIP CHAMBER OF THE PRIMARY FLUID WAS FULL, AND MORE FLUID WAS IN THE PRIMARY BAG THAN THE TOTAL VOLUME TO BE INFUSED AS INDICATED BY THE PUMP. REPORTEDLY, THE HOSPITAL LABORATORY ANALYZED THE PRIMARY BAG AND CONFIRMED IT CONTAINED POTASSIUM. NO PT HARM REPORTED, NO MEDICAL INTERVENTION REQUIRED AND NO ILL EFFECTS EXPERIENCED BY THE PT. THE PRIMARY AND SECONDARY ADMINISTRATION SETS WERE REQUESTED BUT NOT RECEIVED TO DATE. A F/U REPORT WILL BE FILED IF PRODUCT IS RECEIVED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA, SET, ADMINISTRATION FPA CARDINAL HEALTH ALARIS PRODUCT 10015294 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other