BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3869596 · Received April 30, 2014

    Report

    Report Number
    9615050-2014-03142
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 2, 2014
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 POWERED OFF BY ITSELF. THE DEVICE WAS RETURNED TO THE BIOMED DEPT WITH A NOTE FROM THE CLINICAL CONTACT THAT INDICATED, "ON A PT AND STOPPED WORKING." IT WAS LSO REPORTED THAT, "PUMP INFUSION BLOOD AND PLUGGED IN. PT WALKS THROUGH EXAM ROOM TO SEE NURSE PRACTITIONER AND PUMP DIED. PLUGGED BACK IN AND TURNED IT BACK ON AND LATER MAINTENANCE ERROR APPEAR ON THE SCREEN." NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVEN DETAILS WERE AVAILABLE. THERE WER NO REPORTS OF ANY ADVERSE PT EFFECTS OR DELAYS IN CRITICAL THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258447 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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