BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA III INFUSER

    MDR report key: 1931703 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00931
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PUMP DID NOT DELIVER. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "NOT RECOGNIZING PENDANT." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE CUSTOMER CONTACT INDICATED THAT THE PUMP COULD BE PROGRAMMED W/O THE VIAL BEING PROPERLY SEATED INTO THE INJECTOR. NO AUDIBLE ALARM WAS NOTED INDICATING THAT THE VIAL WAS NOT SEATED PROPERLY. THE CUSTOMER CONTACT REPORTED THEN AFTER THE DELIVERY WAS STARTED WITH THE VIAL NOT SEATED PROPERLY, THE DEVICE DISPLAY WAS INCREMENTING; HOWEVER, NO FLUID WAS BEING DELIVERED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAY IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CRITICAL USE. THOUGH REQUESTED, ADD'L INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA III INFUSER 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK