BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLMD PUMP

    MDR report key: 1211257 · Received October 16, 2008

    Report

    Report Number
    2921482-2008-00337
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    July 5, 2008
    Report Date
    September 26, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 A SHOCK. THE CUSTOMER CONTACT REPORTED THE NURSE RECEIVED AN ELECTRICAL SHOCK TO HER RIGHT HAND WHEN PLUGGING IN THE DEVICE INTO THE AC POWER OUTLET. IT WAS REPORTED THE NURSE HAD BLACK SOOT ON HER RIGHT HAND, WAS TACHYCARDIC AND EXPERIENCED A SENSATION OF TEMPERATURE CHANGE IN THE ARMS. AN ELECTROCARDIOGRAM AND AN UNSPECIFIED LABORATORY TEST WERE PERFORMED. THE DEVICE WAS REMOVED FROM THE CLINICAL SETTING. NO FURTHER EVENT DETAILS WERE PROVIDED INCLUDING INFORMATION IF MEDICAL INTERVENTION WAS PROVIDED. FOLLOWING THE EVENT, THE CUSTOMER CONTACT REPORTED THAT THE NURSE CONTINUED TO EXPERIENCE TACHYCARDIA AND HAD FATIGUE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLMD PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other