BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM PUMP

    MDR report key: 1023688 · Received April 1, 2008

    Report

    Report Number
    2921482-2008-00103
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 6, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K953660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 PUMP DELIVERED MORE THAN EXPECTED. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT INDICATED, "THERE WAS A DELIVERY PROBLEM WITH BOTH THE PRIMARY AND THE SECONDARY." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE PUMP DELIVERED MORE THAN EXPECTED FROM THE SECONDARY LINE. REPORTEDLY, THE PUMP DID NOT SWITCH DELIVERY TO THE PRIMARY LINE WHEN THE SECONDARY LINE VOLUME TO BE INFUSED WAS COMPLETED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK