BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXPLUS TRI-FUSE EXTENSION SET

    MDR report key: 3108465 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00326
    Event Type
    Death
    Date Received
    May 1, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CLINICAL EDUCATOR REPORTED AN EXTENSION SET WAS LEAKING IN THE AREA WHERE THE THREE LENGTHS OF TUBING ARE CONNECTED. MEDICATION RUNNING WAS PROPOFOL, MORPHINE AND VERSED. THE BEDSIDE RN IMMEDIATELY CHANGED THE SET. THE PAD UNDER THE PATIENT WAS WET, SO THE SET WAS LEAKING FOR AN UNDETERMINED AMOUNT OF TIME. THE PATIENT WAS ADMITTED ON (B)(6) 2013 AND APPROXIMATELY TWO WEEKS LATER THE PATIENT DIED. UNKNOWN IF EVENT HAD ANYTHING TO DO WITH THE PATIENT'S DEATH. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191033 MAXPLUS TRI-FUSE EXTENSION SET FPA CAREFUSION CORPORATION ME1224 12065225

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death