BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+

    MDR report key: 560534 · Received May 12, 2004

    Report

    Report Number
    2921482-2004-00287
    Event Type
    Malfunction
    Date Received
    May 12, 2004
    Date of Event
    April 6, 2004
    Report Date
    April 13, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN UNDERDELIVERY. IN 2004 AT 0930, LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED "FLUSH" SOLUTION AT A RATE OF 138ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 7ML. THE CUSTOMER CONTACT DID NOT REPORT ANY ISSUES WITH LINE A DELIVERY. LINE B WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ANIDULOFUNGIN AT A RATE OF 138ML/HR, WITH A VTBI OF 200ML, AND A DURATION OF 90 MINUTES. WHEN THE INFUSION WAS COMPLETE, THE NURSE NOTED THAT ON LINE B THERE WERE APPROXIMATELY "37ML LEFT IN THE BAG." AT THIS TIME, THE NURSE REPROGRAMMED LINE B TO DELIVER THE REMAINING MEDICATION AT A RATE OF 138ML/HR. FOLLOWING THE COMPLETION OF THIS SECOND INFUSION, THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other PLUM A+ SOFTWARE MODULE, LIST# 12393.