BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-EM

    MDR report key: 117740 · Received September 5, 1997

    Report

    Report Number
    MW1012034
    Event Type
    Death
    Date Received
    September 5, 1997
    Date of Event
    July 8, 1997
    Report Date
    August 8, 1997
    Manufacturer
    EZ-EM, INC.
    Product Code
    FCD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    JULY 8, 1997 77 YR FEMALE FOR BE AS OUTPATIENT WAS ADMITTED AFTER SUSTAINING A RESPIRATORY ARREST IN THE RADIOLOGY DEPT DURING A BARIUM ENEMA. PT HAD H/O CVA AND WAS ON COUMADIN FOR A-FIB. HAD FLEXIBLE SIGMOIDOSCOPY IN OFFICE WITH NO PROBLEMS. AFTER INSERTION OF RECTAL TUBE PT HAD PROBLEMS WITH HYPOTENSION AND BRADYCARDIA THEN SUSTAINED RESPIRATORY ARREST. DRUGS GIVEN DURING CODE IN RADIOLOGY: FLUIDS, EPINEPHRINE, ATROPINE, AND DOPAMINE. THE PT WAS TRANSPORTED TO CCU WHERE RESUSCITATION CONTINUED. PT WAS NOTED TO HAVE A LARGE AMOUNT OF VAGINAL BLEEDING IN ICU. A SURGERY CONSULT WAS OBTAINED. SURGICAL CONSULT FELT THERE MAY HAVE BEEN A LATEX ALLERGY AND AVOIDED THE USE OF ENEMA BALLOON. NO SIGN OF FISTULA. THERE WAS NOTED TO BE BARIUM IN THE VAGINA. 7/9/97 PT HAD SEVERAL APNEIC EPISODES PROGRESSING TO RESPIRATORY ARREST, PT EXPIRED AT 6 PM; FAMILY DID NOT WANT AUTOPSY. NO INTUBATION WAS DONE AT PT/FAMILY REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-EM BARIUM ENEMA TIP FCD EZ-EM, INC. 8816 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death