BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 1934458 · Received November 23, 2010

    Report

    Report Number
    2921482-2010-00941
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE RESULTING IN THE PT RECEIVING LESS MEDICATION THAN INTENDED. THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CARBOPLATIN, AT A RATE OF 500ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 250ML, FOR AN EXPECTED DURATION OF 30 MINUTES, AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT AFTER 10 MINUTES, THE NURSE NOTED THE PUMP DISPLAYED AN UNSPECIFIED RATE WHICH CHANGED THE EXPECTED DURATION TO 5 HOURS INSTEAD OF THE INTENDED DURATION OF 30 MINUTES. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ TRIPLE NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK