BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 PUMP

    MDR report key: 1190817 · Received September 24, 2008

    Report

    Report Number
    2921482-2008-00302
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 29, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT SOLUTION FROM THE SECONDARY LINE BACKFLOWED INTO THE PRIMARY LINE. AT AN UNSPECIFIED TIME, LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED SOLUTION AT A RATE OF 100 ML/HR. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER PANTALOC 80 MG/100 ML, AT A RATE OF 10 ML/HR, FOR A DURATION OF 10 HRS AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT 5.5 HRS AFTER THE INITIATION OF THE DELIVERY, THE PANTALOC SOLUTION CONTAINER WAS EMPTY. THE CUSTOMER CONTACT REPORTED, "THERE WAS A BACKFLOW IN THE CHAMBER OF MAIN IV." THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM 1.6 PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK