BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD SPANISH NEW

    MDR report key: 2142228 · Received May 26, 2011

    Report

    Report Number
    9615050-2011-00380
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 27, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MEDICATION FASTER THAN INTENDED. THE PRIMARY LINE OF THE PUMP WAS PROGRAMMED TO DELIVER TOTAL PARENTERAL NUTRITION (TPN) AT A RATE OF 62ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 1497ML, FOR A DURATION OF 24 HOURS, AND DELIVERY WAS STARTED. AFTER 19.5 HOURS, IT WAS NOTED THAT THE DELIVERY WAS COMPLETE WHICH WAS 4.5 EARLIER THAN EXPECTED. THE PUMP PROGRAMMING WAS CHECKED BY THE PHARMACY AND THE WARD SUPERVISOR. THE PHYSICIAN WAS NOTIFIED. LAB WORK WAS DRAWN, "MAINLY LOOKING FOR THE GLYCEMIC LEVEL" WHICH WAS REPORTED TO HAVE "NO ALTERATIONS." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE DELIVERED FASTER THAN EXPECTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLD SPANISH NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR PLUMSET, LIST #14000, LOT #UNK