BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA WITH MEDNET

    MDR report key: 1203410 · Received October 15, 2008

    Report

    Report Number
    2921482-2008-00328
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 24, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORT THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER DEMEROL 300MG. NO SPECIFIC PUMP PROGRAMMING PARAMETERS WERE PROVIDED. IN 2008 AT 0520, THE NURSE NOTED "THE PUMP SHOWED EMPTY AT 178MG, SYRINGE WAS EMPTY AND THERE SHOULD HAVE BEEN 122 MG LEFT." THE PUMP WAS REMOVED FROM CLINICAL USE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA WITH MEDNET MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK