BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD SPANISH

    MDR report key: 4113839 · Received September 17, 2014

    Report

    Report Number
    9615050-2014-05283
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT SPARKS AND AN ABNORMAL BURN SMELL WERE NOTED FROM AN UNSPECIFIED LOCATION ON THE DEVICE. AT AN UNSPECIFIED TIME, THE DEVICE WAS DELIVERING MIDAZOLAM AT A RATE OF 10ML/HOUR. NO FURTHER PROGRAMMING PARAMETERS PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THERE WERE SPARKS AND AN ABNORMAL BURN SMELL FROM AN UNSPECIFIED LOCATION ON THE DEVICE. THE DEVICE WAS REMOVED TO BE SENT FOR TESTING AND INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575643 PLUM XLD SPANISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR