BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP DRIVER

    MDR report key: 2202227 · Received August 5, 2011

    Report

    Report Number
    9615050-2011-00592
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PUMP DELIVERED MORE THAN EXPECTED. LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED SOLUTION AT A RATE OF 20ML/HR. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE, TO DELIVER AN UNSPECIFIED CONCENTRATION OF LASIX, AT A RATE OF 10ML/HR, AND THE DELIVERIES WERE STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. REPORTEDLY AFTER AN UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT NOTED THAT "LINE A WAS CLAMPED AND INFUSION WAS DRAWN FROM LINE B AT A RATE OF 30ML/HR SO THE LASIX INFUSED TOO RAPIDLY." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING FURTHER EVENT DETAILS, IF THERE WERE ANY ADVERSE PT EFFECTS OR IF MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ PUMP DRIVER 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE LIST # 12097, SN UNK