BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3111732 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01061
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "DOOR ROLLER IS BROKEN." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, A SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199929 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #12097, SN UNK