BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 2992152 · Received March 1, 2013

    Report

    Report Number
    9615050-2013-00295
    Event Type
    Death
    Date Received
    March 1, 2013
    Date of Event
    January 27, 2013
    Report Date
    February 1, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    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

    REPORT 3 OF 3. THE CUSTOMER CONTACT REPORTED A DEATH WHILE THE DEVICE WAS IN USE. AS INDICATED IN REPORT 2 OF 3, THIS DEVICE WAS OBTAINED AS A REPLACEMENT DEVICE TO INITIATE THE LEVOPHED THERAPY FOR THE PT IN THE CATHETERIZATION LAB WITH DECREASING BLOOD PRESSURE. THE CUSTOMER CONTACT REPORTED A REPLACEMENT TUBING SET WAS OBTAINED AND THE DEVICE WAS PROGRAMMED TO DELIVER LEVOPHED 4MG/250ML. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT WHILE IN THE CATHETERIZATION LAB, THE PT'S BLOOD PRESSURE CONTINUE TO DECREASE TO AN UNSPECIFIED LEVEL AND THE PT WAS REPORTEDLY NOT PERFUSING; THEREFORE, A CODE WAS CALLED. THE CUSTOMER CONTACT REPORTED THAT RESUSCITATION WAS PERFORMED FOR APPROX 20 MINUTES WHEN THE RESUSCITATION MEASURES WERE STOPPED AND THE PT EXPIRED. THE CUSTOMER CONTACT HAS INDICATED THE CAUSE OF DEATH IS UNK. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89517 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death PLUMSET: LIST# 12538, LOT # UNK| PLUM A+ SOFTWARE MODULE: LIST# UNK, SN UNK| LEVOPHED, MANUFACTURER, UNK