BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 1614868 · Received February 19, 2010

    Report

    Report Number
    2921482-2010-00074
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 22, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR RESULTING IN A PATIENT RECEIVING MORE MEDICATION THAN INTENDED. THE PATIENT WAS RECEIVING END OF LIFE PALLIATIVE TREATMENT. THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER DILAUDID 0.1MG/ML AT A RATE OF 4.5ML/HR AND VTBI (VOLUME TO BE INFUSED) OF 45ML AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE ENTIRE 45ML OF DILAUDID HAD BEEN DELIVERED. THE NURSE NOTED THE DEVICE DISPLAYED A RATE OF 45ML/HR INSTEAD OF THE INTENDED RATE OF 4.5ML/HR. THE PATIENT HAD "DECREASED RESPIRATIONS." THE PHYSICIAN WAS NOTIFIED. THE DILAUDID THERAPY WAS DISCONTINUED AND THE PATIENT WAS TREATED WITH AN UNSPECIFIED DOSE OF NARCAN. THE DEVICE WAS NOT REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED AT AN UNSPECIFIED TIME LATER USING THE SAME DEVICE. THE CUSTOMER CONTACT STATED THAT THE PT "RECOVERED" FROM THE EVENT. AFTER A REVIEW OF THE DEVICE PROGRAMMING, THE NURSE NOTED THE CONCENTRATION OF THE DILAUDID HAD BEEN PROGRAMMED AS 1MG/ML INSTEAD OF THE INTENDED 0.1MG/ML. IT WAS REPORTED THE NURSE USED A DRUG LIBRARY THAT WAS EQUIPPED WITH A 1MG/ML CONCENTRATION FOR DILAUDID (AS ASSIGNED TO THE CCU), INSTEAD OF 0.1MG/ML CONCENTRATION (AS ASSIGNED TO THE CARDIAC CCU). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R PLUM A+ SOFTWARE MODULE: LIST # 20792, SN UNK| DILAUDID: MFR UNK