BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER MORPHINE SULFATE INJECTION, USP

    MDR report key: 551372 · Received October 14, 2004

    Report

    Report Number
    551372
    Event Type
    Death
    Date Received
    October 14, 2004
    Date of Event
    October 7, 2004
    Report Date
    October 13, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WITH HX OF CANCER PRESENTED WITH ACUTE ABDOMINAL PAIN, FOUND TO HAVE DISTAL SMALL BOWEL OBSTRUCTION. PT HAD AN ADVANCED DIRECTIVE. PT REFUSED TO SEE SURGEON. PT WAS PLACED ON HOSPICE AND TRANSFERRED TO SNF FOR COMFORT CARE. DURING THE COURSE PT WAS PAIN CONTROLLED WITH MORPHINE PCA. 10/2004 1600 SHIFT THE PT'S CONDITION WAS DOCUMENTED AS "COMATOSE". THE NEXT DAY 0625 - PT CONTINUES UNRESPONSIVE. 0700 - NEW MS (50ML) PCA SYRINGE HUNG. 0731 THE PT'S WAS DOCUMENTED AS "NON RESPONSIVE, RESPIRATION'S SHALLOW AND IRREGULAR. HAVING DIFFICULTY TAKING 02. 1010 - NO HR. 1048 PT PRONOUNCED. NURSES DID POST MORTUM CARE ON THE PT. THE PCA PUMP WITH THE MS SYRINGE WAS TAKEN TO THE NURSES DESK AND THERE IT WAS DISCOVERED DURING THE DISASSEMBLE THAT THE SYRINGE WAS EMPTY. THERE WAS 30MG OF MORPHINE. UNACCOUNTED. THE SYRINGE ON INSPECTION HAD A CRACK RUNNING ON THE SIDE UP PAST THE PLUNGER CAUSING THE MS TO FREE FLOW. THE PLUNGER WAS AT 28CC. THE NURSES REPORTED THAT EARLIER THE FAMILY HAD SPILT 7UP ON THE FLOOR AND THAT IT HAD BEEN WIPPED UP. IT IS UNKNOWN WHETHER SOME OF THAT SPILL CONTAINED MS FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER MORPHINE SULFATE INJECTION, USP * FMF BAXTER HEALTHCARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death