BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM A+ 3 MEDNET SW

    MDR report key: 3202087 · Received June 26, 2013

    Report

    Report Number
    9615050-2013-01751
    Event Type
    Death
    Date Received
    June 26, 2013
    Date of Event
    December 8, 2010
    Report Date
    January 5, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A PT DEATH WHILE THE DEVICE WAS IN USE. AT AN UNSPECIFIED TIME, THE VASOPRESSORS AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PT CODED. IT WAS REPORTED DURING THE CODE THE DEVICE ALARMED WITH AN UNSPECIFIED "HIGH PRESSURE ALARM." AT THAT TIME, THE NURSE COULD NOT CLEAR THE ALARM AND THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO SPECIFIC EVENT DETAILS WERE PROVIDED. IT WAS REPORTED THE PT SURVIVED THE CODE. THE CUSTOMER CONTACT REPORTED THE PT EXPIRED THE NEXT MORNING. THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH. IT WAS REPORTED AN AUTOPSY WAS COMPLETED; HOWEVER, THE RESULTS WERE NOT PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289656 PLUM A+ 3 MEDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death UNSPECIFIED VASOPRESSORS, MFR UNK