Clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy utilizing the fresenius 2008t machine with cdx and the patient event of cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure.
However, there is no documentation of a causal relationship between the adverse event and use of the machine.
Additionally, there is no allegation of a machine malfunction or deficiency reported for this adverse event.
The cause of the patient¿s cardiopulmonary arrest during hd treatment was attributed to a physiological condition for which the patient required open heart surgery.
Cardiovascular disease is present in greater than 50% of patients undergoing dialysis with 40% of these patients having coronary heart disease.
Based on the available information and no allegation of a malfunction or deficiency, the fresenius 2008t machine with cdx can be excluded as the cause of the patient¿s cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure.
Plant investigation: the plant investigation is in process.
A supplemental mdr will be submitted upon completion of this activity.
.
|