[1198]
Patient is an oncology patient who had a hickman subcutaneous port inserted on 9/3/92. On 12/2/92 at 1:00 pm while she was at home in her kitchen, she noted that her heart rate was irregular. Her pulse 90 and irregular. She arrived in er at 1:40 pm - heart rate was 220. Unable to control rate with medication. An x-ray revealed infusa port fragment in inferior vena cava. Sheath fragment removed intact without dificulty. Patient doing well 12/3/92. Catheter removed. Patient has both partsdevice labeled for single use. Patient medical status prior to event: satisfactory 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, visual examination. Results of evaluation: material degradation/deterioration, telemetry failure, none or unknown, port. Conclusion: device failed during assembly, device failure directly caused event, none or unknown. 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