[100634]
Hemocleanse inc customer complaint rec'd on 10/31/1997, stated that during a standard treatment of a 26 yr old male suffering from acute hepatic failure secondary to a bone marrow transplant for leukemia, blood flow rates, as measured by the biologic-dt machine, suddenly dropped from normal to very low. In this event the operator's manual instructs the user to 1) check the pt vascular access for kinks, 2) check the disposable tubing for obstructions, and if no problem becomes evident 3) press "rinse" and add heparin if indicated by reduced act (parameters also provided in labeling). After checking the catheter, flows reportedly improved but between the treatment time of four hrs and five hrs the problem resurfaced. The operator's manual again states to "rinse", but if low blood flow persists, the treatment should be terminated. The treatment was eventually terminated at five and one half hrs. Normal treatment time is six hrs. The initial rptr of the event state that multiple untrained nurses were involved in the treatment, and that the physician in charge had to leave the scene. The machine had originally been programmed to remove 1000 ml of ultrafiltrate from the pt, but seven or eight rinses were performed by the various nurses caring for the pt. Because any particular nurse was unaware of the actions of another, the pt ended up with a resultant positive fluid balance of 450 ml (0. 9% normal saline). It is reported that the next morning the pt developed pulmonary edema. It is assumed that normal intervention for pulmonary edema was performed but more info is required. The pt expired two days later; however, the rptr noted that death was not a result of the incident.
Patient Sequence No: 1, Text Type: D, B5