Actual device was evaluated.
Performance tests were completed, including the standard accuracy tests, pressure tests and the device was run at the same parameters/settings the customer used.
A visual inspection of the device exterior and interior was completed.
Exterior damage was noted on battery door, front bezel and rear case.
Results: fluid ingress (brown residue) was discovered internally on the pcb, front and back case and various other internal components.
Device performed to specifications during the performance tests conducted at moog.
Could not duplicate the failure.
Fluid ingress likely caused short circuits, which led to the pump communication signals to be adversely affected; i.
Signals did not get sent or signals were not received correctly due to the presence of fluid on the pcb components.
Conclusion: device failure (fluid ingress shorted the pcb) caused by external damage and subsequent fluid ingress directly caused pump to not detect over delivery.
Device experienced 53 alarms (13 error code 10, 11 error code 15 and 29 occlusion) from (b) (6) before the over delivery occurred.
The pump had obvious problems and the labeling clearly states if there is damage, shows repeated error codes or indicates its not performing correctly to return the pump to the health care provider/manufacturer.
The device passed all functional/performance criteria.
Over delivery could not be duplicated.
The information in this report does not constitute an admission that the product caused or contributed to the incident.
An (b) (6) year old, terminally ill (end stage cancer), home hospice, patient, was ordered an infusion of dilaudid with a continuous basal rate of 0.
5mg/hr of 500mg in a 0.
5mg/hr as needed every 15 minutes.
While the nurse was programming and attempting to run the pump, it experienced 41 error codes or alarms.
A replacement pump was attempted and also experienced error codes.
The caregiver returned to this pump ((b) (4)) and then it infused for about 2 hours.
At that point the pump experienced an up occlusion alarm and the bag was observed to be empty and the patient had deceased.