EZ-EM
Received Sep 5, 1997 · Event occurred Jul 8, 1997
Report MW1012034 · MDR key 117740
Device
Generic name
Barium Enema Tip
Manufacturer
Ez-em, Inc.Model number
8816Catalog number
8816-CATALOG # FOR MFR
Lot number
*
Product problems
- Difficult to Insert
- Migration or Expulsion of Device
Patient
77 YR
- Apnea
- Bleeding
- Bradycardia
- Death
- Respiratory arrest
Narrative
Description of Event or Problem
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.