BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIM SYM SET2CIY-SIT

    MDR report key: 1691328 · Received May 12, 2010

    Report

    Report Number
    9615050-2010-00088
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 4, 2010
    Report Date
    April 15, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY, DUE TO THE INABILITY TO DELIVER MEDICATION THROUGH A CLAVE PORT. THE TUBING SET WAS BEING USED TO DELIVER UNSPECIFIED SOLUTIONS VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE PATIENT WENT INTO CARDIAC ARREST. IT WAS REPORTED THAT THE STAFF WERE UNABLE TO DELIVER AN UNSPECIFIED MEDICATION IN A PREFILLED SYRINGE THROUGH THE DISTAL CLAVE PORT DURING A CODE. THE TUBING SET WAS REMOVED FROM THE PUMP, AND THE STAFF UNSUCCESSFULLY ATTEMPTED TO DELIVER THE MEDICATION WITH THE PREFILLED SYRINGE THROUGH THE DISTAL CLAVE PORT. THE TUBING SET WAS REPLACED AND THE MEDICATION WAS DELIVERED. IT WAS REPORTED THAT A DELAY OF THERAPY CRITICAL FOR THE PATIENT OCCURRED DUE TO THE INABILITY TO DELIVER THE MEDICATION AND THE TIME TO PREPARE THE REPLACEMENT TUBING SET. AT AN UNSPECIFIED TIME, IT WAS REPORTED, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING DIAGNOSIS AND AUTOPSY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM SET2CIY-SIT 80FRN FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death UNSPECIFIED ABBOJETCT PREFILLED SYRINGE:| LIST# UNK, LOT# UNK