Description of Event or Problem · 1
5/22/92 PATIENT WAS READMITTED TO OTTERBEIN-LEBANON FOLLOWING A BRAIN STEM HEMORRHAGE DUE TO PROBABLE RT. SUPERIOR CEREBRAL ARTERY ANEURYM. SHE WAS UNRESPONSIVE WITH NO REASONABLE HOPE OF RECOVERY. SHE HAD BILATERAL LUNG WHEEZES WHEN DISCHARGED FROM THE HOSPITAL. A NASAL GASTRIC TUBE WAS IN PLACE WITH A CONTINUOUS FEEDING OF ENSURE AT 30CC. PER HOUR. 5/23/92 11:30 A.M. NG TUBE WAS DISLODGED AND A NEW #14 TUBE WAS REINSERTED BY A R.N. PATIENT HAD TOLERATED 3-11 AND 11-7 FEEDING WITHOUT DIFFICULTY. TEMPERATURE NORMAL. RESPIRATIONS 20 WITH 10 SECOND PERIODS OF APNEA. 5/24/92 8:00 A.M. TOLERATED FEEDING LAST 3-11 AND 11-7 SHIFTS. AT THIS TIME, ORAL DRAINAGE OF SMALL AMOUNT OF TAN MATERIAL AND CLEAR NASAL DRAINAGE NOTED. TUBE PLACEMENT RECHECKED AND ODAY. TEMPERATURE AND RESPIRATION REMAIN UNCHANGED. 5/24/92 1:30 P.M. TEMPERATURE 102 RECTAL TAN COLORED DRAINAGE NOTED FROM NOSE. TUBE PLACEMENT RECHECKED AND ASPIRATED STOMACH CONTENTS. REMOVED TUBE BECAUSE OF NASAL DRAINAGE. AT THIS TIME A 1/4 INCH SLIT IN TUBE WAS NOTED, MIDWAY BETWEEN DISTAL SECOND AND THIRD MARKING ON TUBE. A NEW TUBE WAS INSERTED WITHOUT DIFFICULTY. HAVING CLEAR FROTHY DRAINAGE FROM MOUTH. NO CONGESTION OF CHEST OR WHEEZING WAS NOTED.5/25/92 12:OO A.M. LUNG FIELD CLEAR WITH NASO-GASTRIC TUBE PATENT AND FEEDING INFUSING @ 30 CC/HR. TEMPERATURE 99.8 DEGREE RECTALLY. 6:00 A.M. INCREASED LUNG CONGESTION THRU THE NIGHT WITH OCCASIONAL LOOSE NON-PRODUCTIVE COUGH. 2:30 P.M. RESPIRATIONS HAD BECOME MORE LABORED THRU THE DAY. TEMPERATURE 101.4 DEGREE R.5/26/92 TO 5/28/92 PATIENT CONTINUED TO HAVE FEVER 101.2 DEGREE R. ON CONTINOUS OXYGEN AT 2 L. PHYSICIAN EXAMINED PATIENT - DIAGNOSIS - POSSIBLE ASPIRATION PNEUMONIA. FAMILY HAS REQUESTED NO TREATMENT SINCE HOSPITALIZATION. COMFORT MEASURES ONLY WAS ORDERED. 6/1/92 PATIENTS CONDITION REMAINS VERY CRITICAL. EVEN THOUGH PATIENT HAS POSSIBLE PNEUMONIA THE DOCTOR IS RELATING HIGH TEMPERATURE TO THE BRAINSTEM STROKEDEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, INVALID DATA. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.