BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLM APL V13.4 ABG

    MDR report key: 1417108 · Received July 16, 2009

    Report

    Report Number
    2921482-2009-00251
    Event Type
    Death
    Date Received
    July 16, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 16, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. PRODUCT LABELING STATES "NOTE: WHEN RATE FOR LINE A PLUS RATE FOR LINE B IS GREATER THAN VALID RATE RANGES, A 'CONCURRENCY VIOLATION' ALARM WILL EXPLAIN WHY THE SECOND LINE DID NOT START." THE MAXIMUM CONCURRENT DELIVERY RATE IS 500ML/HR CUMULATIVE LINES A PLUS B.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE RESULTING IN A DELAY OF CRITICAL THERAPY. AT 2112, THE PATIENT'S BLOOD PRESSURE WAS UNDETECTABLE, AND A CODE WAS CALLED. AT THIS TIME, LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER 0.9% SALINE AT A RATE OF 999ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 2127, THE PHYSICIAN ORDERED THE PATIENT TO RECEIVE AN UNSPECIFIED CONCENTRATION OF LEVOPHED. REPORTEDLY, ONE NURSE INFORMED A SECOND NURSE THAT DUE TO THE HIGH DELIVERY RATE PROGRAMMED ON LINE A, LINE B COULD NOT BE USED TO DELIVER THE PRESCRIBED LEVOPHED; HOWEVER, IT WAS REPORTED THE SECOND NURSE ATTEMPTED TO PROGRAM LINE B TO DELIVER LEVOPHED AT A RATE OF "50 OR 75ML/HR." AT THIS TIME, THE PUMP ALARMED FOR A CONCURRENCY VIOLATION. AT 2135, A SECOND PUMP WAS OBTAINED AND THE LEVOPHED DELIVERY WAS STARTED. AT 2214, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. THE CUSTOMER CONTACT STATED THAT SUBSEQUENT TO THE REPORTED EVENT, THE NURSES WERE RETRAINED ON THE MAXIMUM DELIVERY RATE ALLOWED WHEN THE PUMP IS PROGRAMMED IN THE CONCURRENT MODE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM APL V13.4 ABG 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INDUSTRIES| LEVOPHED| PLUM A+ SOFTWARE MODULE