BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD 110V L.A.

    MDR report key: 4152429 · Received October 3, 2014

    Report

    Report Number
    9615050-2014-05463
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 15, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE DEVICE DOOR ROLLER PIN WAS MISSING. THE DEVICE WAS RETURNED TO THE ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "DAMAGED". NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS, DELAYS IN CRITICAL THERAPIES, OR NECESSITY FOR MEDICAL INTERVENTIONS WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER PIN WAS MISSING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617560 PLUM XLD 110V L.A. 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK