BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ VS11.51 E

    MDR report key: 1352671 · Received March 26, 2009

    Report

    Report Number
    2921482-2009-00106
    Event Type
    Injury
    Date Received
    March 26, 2009
    Date of Event
    February 23, 2009
    Report Date
    February 24, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE PUMP WAS IN USE. AT 1045, THE PUMP WAS PROGRAMMED TO DELIVER 210MG OF TAXOL, FOR A DURATION OF 180 MINUTES, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1300, THE PT REPORTED PAIN IN HER LEFT FOREARM AT THE INSERTION SITE OF THE IV CATHETER. AT THIS TIME, THE NURSE NOTED EXTRAVASATION AT THE IV SITE IN THE PT'S ARM. THE DELIVERY WAS STOPPED AND ICE WAS PLACED AT THE SITE. THE PHYSICIAN WAS NOTIFIED. THE PT WAS TREATED WITH AN UNSPECIFIED AMOUNT OF SOLUMEDROL ADMINISTERED THROUGH THE IV CATHETER. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ VS11.51 E 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention TAXOL