BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2181056 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00488
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 7, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. IT WAS REPORTED THAT LINE B OF THE DEVICE WAS PROGRAMMED IN THE PIGGYBACK MODE TO DELIVER 340ML OF RITUXIMAB AND THE DELIVERY WAS STARTED. LINE A HAD BEEN PROGRAMMED TO DELIVER 30ML OF AN UNSPECIFIED IV SOLUTION TO FLUSH THE LINE FOLLOWING THE RITUXIMAB DELIVERY. AT 1920, THE DEVICE ALARMED THAT THE DELIVERY WAS COMPLETE. AT THIS TIME, THE NURSE NOTED THAT THERE WAS APPROXIMATELY 30 TO 40ML OF MEDICATION REMAINING IN THE RITUXIMAB CONTAINER; HOWEVER, THE DEVICE DISPLAYED A VOLUME INFUSED OF 334ML. IT WAS REPORTED THAT LINE B WAS REPROGRAMMED TO DELIVER THE REMAINDER OF THE RITUXIMAB. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THIS PATIENT. 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+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1