BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ PUMP

    MDR report key: 1161203 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00283
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE DEVICE WAS PROGRAMMED TO DELIVER HEPARIN 25,000 UNITS/500ML. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. APPROX 30 MINUTES AFTER THE DELIVERY WAS STARTED, IT WAS NOTED THAT THE DEVICE WAS DELIVERING AT A RATE OF 360ML/HR. IT WAS REPORTED THE "PT RECEIVED 22,000 UNITS OF HEPARIN." A PARTIAL THROMBOPLASTIN TIME WAS DRAWN AND WAS REPORTED AS "HIGH." THE PT WAS TREATED WITH 50 MG OF PROTAMINE SULFATE IV. THE CUSTOMER CONTACT STATED THAT AFTER THE EVENT, IT WAS NOTED THE DRUG LIBRARY DEFAULT FOR HEPARIN IN THE DEVICE WAS CONFIGURED FOR UNITS/HR INSTEAD OF THE INTENDED UNITS/KG/HR. THERE WERE NO REPORTED ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R HEPARIN MANUFACTURED BY HOSPIRA INC.| PLUM A+ SOFTWARE MODULE