BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PUMP

    MDR report key: 2894522 · Received November 25, 2008

    Report

    Report Number
    2921482-2008-00396
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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 PATIENT RECEIVED LESS MEDICATION THAN INTENDED. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED ANTIBIOTIC, AT AN UNSPECIFIED RATE, WITH A VOLUME TO BE INFUSED (VTBI) OF 50 ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME WHEN THE DELIVERY WAS EXPECTED TO BE COMPLETE, THE NURSE NOTED THAT APPROXIMATELY 25 ML OF MEDICATION REMAINED IN THE SOLUTION BAG. THE DEVICE WAS REPROGRAMMED AND THE DELIVERY WAS COMPLETED. AT AN UNSPECIFIED TIME LATER, THE DEVICE WAS PROGRAMMED TO DELIVER ANOTHER UNSPECIFIED ANTIBIOTIC, AT AN UNSPECIFIED RATE, AND VTBI OF 100 ML AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME WHEN THE DELIVERY WAS EXPECTED TO BE COMPLETE, THE NURSE NOTED APPROXIMATELY 50 ML REMAINING IN THE SOLUTION BAG. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1