BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 PUMP

    MDR report key: 1211249 · Received October 16, 2008

    Report

    Report Number
    2921482-2008-00330
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER, THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE SECONDARY LINE OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF GENTAMYCIN FOR A DURATION OF ONE HOUR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PUMP DISPLAY INDICATED THE SECONDARY DELIVERY WAS COMPLETE; HOWEVER, APPROXIMATELY 25% OF THE MEDICATION REMAINED IN THE SOLUTION BAG. 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 1.6 PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT# UNK| MANUFACTURED BY BAXTER INTERNATIONAL| SECONDARY TUBING SET: