BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ UK WITH 3PIN

    MDR report key: 2801611 · Received October 18, 2012

    Report

    Report Number
    9615050-2012-01246
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    April 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DELIVERED LESS THAN INTENDED. THE DEVICE WAS RETURNED TO THE USER FACILITY'S CLINICAL ENGINEERING DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING, THE DEVICE DELIVERED LESS THAN INTENDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ UK WITH 3PIN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE: LIST #12097,| SN (B)(4)