The instrument gave a low fluid alarm message.When the lab technician opened the instrument door fluid had spilled inside the instrument, and smoke was coming from the reagent probe.The lab technician unplugged the instrument.No flames were observed, just smoke coming from the probe.Slide staining was repeated on a backup instrument.The investigation is ongoing to determine the root cause.
|
For the users of the device (e.G., laboratory personnel), it is likely that the electrical short circuits were caused by leakage of the instrument.(the flexible tubing running through the pinch valve in the z-head burst.This caused the electrical components in the head to short out causing the seen smoke.) this can lead to smoke and have the potential to escalate to fire.In a worst case scenario, this could lead to death or other physical harm and/or damage to property.The potential for harm in this scenario is catastrophic (severity score of 5).In this case an alarm aided in the detection of the smoke but in general, laboratories are equipped with smoke alarms.Furthermore, smoke and the smell of smoke is easily detectable (detectability score of 2).This incident, should it recur, could lead to several hazardous situations and potential harm to users and/or patients.These include physical harm and/or property damage due to fire (users), and the need for a rebiopsy procedure and/or a clinically-significant delay in obtaining a diagnostic result (patients).However, the chance of serious harm is considered very unlikely due to the reasons given above.The incident is assessed not reportable.Reason for reporting the initial mdr report was due to the missing root cause.No complaints concerning smoke on the autostainer have been previously reported.Since the run was not completed the staining run was repeated on another instrument.Besides, (b)(4).And other manufacturers provide alternate products for diagnostic testing of formalin-fixed, paraffin-embedded tissue sections.This investigation is closed.
|