[3897]
Emploee states that all of pre-treatment safety checks were deformed and proceeded to place patient on dialysis at 1:00 pm. At 3:00 nurse noted that patient's arterial and venous pressures were significantly elevated. 200 cc bolus of normal saline administered pressure levels at acceptable level. 4:00 pm it was note pressure levels up again. 4:15 another 200cc bolus normal saline given. Nurse placed clamp on saline line afterwards. 4:25 it was noted that saline bag was empty. Patient stated "i feel funny in my chest". Venous and arterial lines clamped off manually. Patient placed on side per standard protocol for a suspected air infusion. Patient went into respiratory arrest and a code was called. Patient transferred to hospital. Died may 13, 1993. Nurse states that she put clamp on the saline line after the 4:15 pm administration of saline. When she went to patient to manually clamp off the lines, after the bag was noted to be empty, she said that she saw the clamp lying on the floor. Question the possibility that the clamp did not click closed. During the investigation it was noted that a week prior to the incident the motherboard was shorted out in the area tha controls the internal alarm system. The motherboard is in a very vulnerable position and easily accessed by foreign substances that could cause a short in the systemdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: component failure, electrical problem, foreign material contamination, failure to follow instructions, incorrect technique/procedure, unanticipated short term complication of procedure, alarm failure, component failure. Conclusion: device failure occurred and was related to event, device failure indirectly contributed to event, user error contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service, device temporarily removed from service, user education provided, inserviced by other facility staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5