BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ UK WITH 3PIN

    MDR report key: 1950279 · Received December 13, 2010

    Report

    Report Number
    2921482-2010-00994
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE PUMP DELIVERED A MEASURED VOLUME OF 19.81ML FROM AN EXPECTED DELIVERY OF 20.0ML. DELIVERY ACCURACY FOR THIS PUMP REQUIRES DELIVERY OF 20ML +/-1ML (+/-5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE PUMP HISTORY WAS DOWNLOADED AT THE USER FACILITY. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE OR PROGRAMMING PARAMETERS; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. 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 PT RECEIVED LESS MEDICATION THAN INTENDED. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CHEMOTHERAPY MEDICATION AT A RATE OF 503 ML, FOR A DURATION OF ONE HOUR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT AFTER ONE HOUR, THE DEVICE ALARMED WITH AN UNSPECIFIED ALARM CODE. AT THIS TIME, THE NURSE NOTED THAT "VERY LITTLE" OF THE MEDICATION HAD INFUSED. 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 INCLUDING WHEN THE DEVICE WAS REMOVED FROM CLINICAL USE AND IF THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ UK WITH 3PIN 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST# 12097| (B)(4)