BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM 1.6 PUMP

    MDR report key: 1192088 · Received October 7, 2008

    Report

    Report Number
    2921482-2008-00319
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 15, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AT A RATE OF 3.6ML/HR WITH AN UNSPECIFIED VOLUME TO BE INFUSED (VTBI) AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT APPROX TWO HOURS LATER, 136ML HAD BEEN DELIVERED. THE CUSTOMER CONTACT REPORTED THAT THE PT "CODED," BUT WAS REPORTEDLY "STABLE" AFTER THE EVENT. NO SPECIFIC EVENT DETAILS OR MEDICAL INTERVENTIONS WERE PROVIDED. THOUGH REQUESTED, NO ADD'L 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 Life Threatening| R