BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS100ML BURETTE77PPR

    MDR report key: 2427226 · Received January 5, 2012

    Report

    Report Number
    9615050-2012-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    November 9, 2011
    Report Date
    December 6, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THE REPORTER WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFO WAS NOT OBTAINED. 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 NO FLOW. THE SOLUSET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NOREPINEPHRINE, AT AN UNSPECIFIED RATE, VIA GRAVITY. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE FLOAT VALVE OF THE SOLUSET REMAINED IN THE CLOSED POSITION. THE CUSTOMER CONTACT REPORTED THAT THE PT'S BLOOD PRESSURE DECREASED TO A REPORTED "55". IT WAS REPORTED THAT THE HEALTHCARE PROVIDER MANIPULATED THE SOLUSET AND THE FLOAT VALVE OPENED. THE CUSTOMER CONTACT REPORTED THE PT "RECOVERED"; HOWEVER, NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THERE WAS NO ADVERSE PT EVENT OR CRITICAL DELAY IN THERAPY. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS100ML BURETTE77PPR 80FPK FPK HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK