BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA III INFUSER

    MDR report key: 2043232 · Received February 24, 2011

    Report

    Report Number
    9615050-2011-00113
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 26, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 DEVICE DID NOT DELIVER. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE SULFATE 1MG/ML, IN THE PCA ONLY MODE, WITH A 2MG PCA DOSE, A 10 MINUTE PT LOCKOUT, AND A 30MG UNSPECIFIED DOSE LIMIT. THE CUSTOMER CONTACT REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, DURING NURSING ROUNDS, "THE DISPLAY READ 44 DELIVERED AND THE VIAL STILL FULL." IT WAS REPORTED THAT AT AN UNSPECIFIED TIME, THE PT'S PAIN LEVEL WAS "10/10". THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR