BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 W/DATAPORT

    MDR report key: 3832211 · Received March 7, 2014

    Report

    Report Number
    9615050-2014-01784
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE FRONT CASE DOOR HANDLE, THE SHIELD SPLASH GUARD AND THE DOOR COVER WAS DAMAGED FROM AN EXTERNAL SOURCE OF HEAT. THERE WERE NO SIGNS OF CORROSION OR BURNING INSIDE OF THE DEVICE. THE PROBABLE CAUSE OF THE EXTERNAL HEAT DAMAGE IS CUSTOMER ABUSE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DOOR OF THE DEVICE WAS BURNED. AT AN UNSPECIFIED TIME, IT WAS REPORTED THE DEVICE WAS USED FOR AMBULANCE TRANSPORT. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED WHEN THE TRANSPORT WAS COMPLETED IT WAS NOTED THE PLASTIC OF THE COMPARTMENT OF THE CASSETTE WAS DEFORMED. THE CUSTOMER CONTACT REPORTED THERE WERE NO FIRE MARKS OR CHARRING. IT WAS REPORTED THAT THE DEVICE MAY HAVE BEEN NEAR A SOURCE OF HEAT DURING THE TRANSPORT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT OR THE STAFF. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138501 PLUM 1.6 W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK