[16271196]
Patient was 56 year old female with history of hypertension, cardiomegaly and concentric lvh and chronic renal insufficiency requiring hemodialysis. The patient was admitted for outpatient placement of a perma-cath dialysis access catheter. The patient had an injury from dilator in the infraclavicular subclavian vein on the right which caused exsanguination into the chest cavity. Despite placement of tube thoracostomy and attempted resuscitation with blood and the patient's salvaged bloodd from the chest tube, and multiple cardiac drugs in attempt to resuscitate, the patient expired on the or table secondary to exsanguination of the chest cavity from an injury of the infraclavicular vein by a dilator used for placement of a perma-cath. Event not report as "product related" until 1/21/92device labeled for single use. Patient medical status prior to event: fair 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: inherent risk of procedure, unanticipated adverse reaction - short term. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5