BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2`

    MDR report key: 2191057 · Received July 25, 2011

    Report

    Report Number
    9615050-2011-00563
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 5, 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 ON (B)(4) 2011. 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 EVENT REPORTED BY THE CUSTOMER; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT PROVIDED. 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 AIR IN THE TUBING DISTAL TO THE DEVICE WITH NO DEVICE ALARM. LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER 100 ML OF AVASTIN, FOR A DURATION OF 30 MINUTES, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 25 MINUTES, THE DEVICE ALARMED FOR AIR-IN-LINE. AT THIS TIME, THE NURSE NOTED, THE AVASTIN CONTAINER WAS EMPTY AND THAT THERE WAS APPROX 2 INCHES OF AIR IN THE TUBING DISTAL TO THE DEVICE. NO AIR REACHED THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. 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` 80 FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR PLUMSET, LIST# 14687, LOT# 020795H| PLUM A+ SOFTWARE MODULE: LIST#20791, SN (B)(4)