MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48

Model Number AS48030

Device Problems Fluid/Blood Leak (1250); Smoking (1585); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

According to the lab technician there was a full test kit in the instrument.He therefore thought it was odd that it would be low on any particular reagent.The drip tray on the arm was full of liquid.Root cause investigation is ongoing.

Event Description

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.

Manufacturer Narrative

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.

Event Description

Please see additional manufacturer narrative section.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: mani siravanta ; 6392 via real; carpinteria, CA 93013 ; 8055665462
• MDR Report Key: 5586992
• MDR Text Key: 44149800
• Report Number: 2022180-2016-00001
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS48030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other