BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2191066 · Received July 25, 2011

    Report

    Report Number
    9615050-2011-00561
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES THAT THERE IS NO PROGRAMMING THAT CORRELATES WITH THE PROGRAMMING REPORTED BY THE CUSTOMER CONTACT; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT PROVIDED. THIS REPORT REPRESENTED ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL OF THE DEVICE WITH NO DEVICE ALARM. LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER LEUCOVORIN 750 MG/250ML, AT A RATE OF 140ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 280ML, FOR A DURATION OF 2 HOURS. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER AN UNSPECIFIED CONCENTRATION OF OXALIPLATIN, FOR A DURATION OF 2 HOURS, AND THE DELIVERIES WERE STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROXIMATELY 2 HOURS, THE DEVICE ALARMED FOR AIR-IN-LINE. AT THIS TIME, THE NURSE NOTED THAT THE LEUCOVORIN CONTAINER WAS EMPTY AND THAT THERE WAS APPROX 15 INCHES AIR IN THE TUBING DISTAL TO THE DEVICE. IT WAS REPORTED THAT THERE WAS STILL A "MINIMAL AMOUNT" OF OXALIPLATIN LEFT IN THE CONTAINER ON LINE B. NO AIR REACHED THE PT. THE TUBING SET WAS REPLACED AND THE OXALIPLATIN THERAPY WAS RESUMED USING THE SAME DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO 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 62 YR LIST# 20791, SN (B)(4)| PLUM A+ SOFTWARE MODULE:| PLUMSET: LIST# 14687, LOT# 020795H