[97]
Patient was admitted on 12/30/91 at 2209. She had been on naprosyn anti-inflammatory medication since august. Five days prior to admission she had become mausea. The naprosyn had been discontinued and zantac started. The day of admission she had a large bright red stool with coffee ground material aspirated fromr the stomach. A gastrointestinal consultant was called in. On 12/31/91 at 1330 an esophagogastroduodenoscopy was performed with a biopsy and possible ulceration treated with heater probe with hemostasis acheived. Patient had to lie with her right side down because of scoliosis. 5 mg. Of intravenous versed was given prior to hurricaine spray of the oropharynx. Ekg remained unchanged with multiple pvc's noted, possible ulceration in this area. At 1650, patient was very dyspneic and uncomfortable with abdominal distension and pain. An abdominal series was obtained which noted massive free intra-abdominal air. Chest x-ray showed free air under the diaphragm. The patient was returned to surgery at 1850 on 12/31/91 for an exploratory laparotomy, closure of perforation of duodenum, performed by a general surgeon. The patient tolerated the procedure well and was sent to recovery at 2020 in fair condition on a ventilator. She received 4 units of rbc's and 6 units of fresh frozen plasma. Wbc's were 15. 1 (12/30), 24. 6 (12/31), 20. 8 (12/31), and 18. 9 (1/1). Platelets were 487 (12/30), 477 (12/31), 395 (12/31), and 286 (1/1). Pro time was 20. 0 sec (12/30), 17. 9 sec (12/31), and 15. 3 sec (1/1). Blood gas results postoperatively on 1/1 were 7. 339 ph, pc02 27. 8, and p02 of 123, early; 7. 176 ph, 33. 1 pc02, and 66 po2 at 1242; and 6. 977 ph, 29. 8 pc02, and 73 p02 at 1845. Swan ganz catheter was inserted at 0830 on 1/1/92. The patient was anuric and hypotensive. The patient's father wanted a dnr (do not resuscitate) based on his knowledge of his daughter. Patient pronounced dead at 0115 on 1/2/92. No autopsy was done. Device will be tested by an independent evaluator prior to being tested by manufacturerdevice not labeled for single use. Patient medical status prior to event: fair condition. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: user facility biomedical/bioengineering department. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5