Description of Event or Problem · 1
11-18-92 AT 1:45 A.M. RESIDENT BEGAN COUGHING EXPECTORATED 150 CC BRIGHT RED BLOODY MUCOUS AND COMPLAINED OF FEELING "PRESSURE" WHEN TRYING TO BREATH. HE CONTINUE TO EXPECTORATE 350 CC OF BRIGHT RED BLOOD WITHIN THE NEXT 43 MINUTES. PHYSICIAN WAS NOTIFIED AND ORDER OBTAINED TO TRANSFER TO HOSPITAL FOR FURTHER EVALUATION. ACCORDING TO THE HOSPITAL PHYSICIAN NOTES, "THE PATIENT WAS TAKEN TO THE ENDOSCOPY SUITE WHERE HE UNDERWENT UPPER GASTROINTESTINAL ENDOSCOPY. UPON ADVANCEMENT OF THE ENDOSCOPE INTO THE EG JUNCTION, ONE COULD SEE THE TIP OF THE GASTROSTOMY TUBE IN THEDISYTAL ESOPHAGUS. THE GASTROSTOMY TUBE WAS THEN DEFLATED AND REMOVED. WE WERE ABLE TO PERFORM AN UPPER GASTROINTESTNAL ENDOSCOPY AND THE PATIENT DID HAVE GASTRITIS IN THE PROXIMAL PORTION OF THE STOMACH; HOWEVER, THE PATIENT DID HAVE FAIRLY PROMINENT HIATUS HERNIA WITH LINEAR EROSIONS MOST LIKELY DUE TO PRESSURE NECROSIS FROM THE PRESENCE OF THE GASTROSTOMY BALLOON IN THE HIATUS HERNIA. THIS WAS TAKEN OUT AND PEG BUTTON WAS INSERTED." THE PATIENT WAS MONITORED FOR TWO DAYS AT THE HOSPITAL AND THEN RETURNED BACK TO THE NURSING FACILITY FOR FURTHER CAREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.