BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARD XL LATIN AM

    MDR report key: 1760927 · Received July 14, 2010

    Report

    Report Number
    2921482-2010-00513
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 14, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K953660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON 06/24/2010. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED "SPARKS" WERE NOTED FROM THE FEMALE END OF THE AC POWER CORD. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THAT "SPARKS" WERE COMING FROM THE BACK OF THE DEVICE AND THAT THE PLUG AT THE FEMALE END OF THE AC POWER CORD WAS "BURNED." THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING, WHAT WAS DONE WITH THE DEVICE AT THE TIME THE SPARKS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR