MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC VENTANA HE 600 SYSTEM; SLIDE STAINER, AUTOMATED

Catalog Number 06917259001

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425); Electrical Shorting (2926)

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

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

From the investigation of returned parts it was noted that there were obvious signs of fluid ingress on the top surface of solvent transfer manifold (black delrin part).Darkened fluid pooling was visually obvious in four led locations around d1, d2, d3 and d4, as well as the resistors r1 and r2.Light fluid staining was present in the vicinity of d5, d6, and d7.J1 connector appeared to be free of fluid residuals.When checking the led status using a digital multimeter, 8 of the 9 green leds lit.D4 failed to light up while d6 lit weakly.When +24 vdc power is applied to the csm led pcba, five of the leds lit green (d1, d3, d5, d7, and d9) whereas four did not (d2, d4, d6, d8).This is expected if one or more led in the same series is defective.When placing d4 under a microscope, the surface was visibly more distorted than other leds on the pcba.In addition, there appears to be a black spot in the junction area where the semiconductor is housed,which may suspect a burnout at the junction.A similarly blackened area is noticed when observing d6 under a microscope.Capa has been initiated for the issue and root cause investigation is ongoing.Corrective and preventive measures will be implemented, as appropriate.At affected customer sites, roche local field service representatives will remove the cable that conducts electricity to the coverslipper module led pcba.Site visits will be scheduled as appropriate.

Event Description

A us customer alleged that a small fluid leak dripped onto the led status pcb of the shield manifold assembly causing it to short out.The lab operator noted that they smelled a burnt odor.No fire or lab evacuations were alleged; and no harm or injury occurred.A local field service engineer (fse) visited the customer site, and repaired the ventana he 600 instrument and replaced the damaged shield manifold assembly.The instrument is now within acceptable operating specifications.

Manufacturer Narrative

The root cause investigation specific to the electrical aspects of the he600 instrument has been completed.  the burnt csm on he600 instrument was caused by the generation of sparks from the j1 connector on the csm led pcba, which ignited the delrin (plastic) manifold bracket.The sparking on the j1 connector was caused by acs fluid getting inside the j1 connector.The design of the delrin block contributes to acs fluid getting into the connector due to a channel that the cable rests, which acts to direct fluids towards the connector, once fluid enters the channel.The root cause investigation specific to the systemic fluid path design leading to fluid leaks is completed and has concluded the issue is related to material incompatibility.Improvements have been made to the ventana design process, including design readiness and material compatibility work instructions and checklists.In jan-2020, manufacturing instructions were updated to release he600 instruments with the cable removed.In sep-2020, a new exchange valve polypropylene tee fitting was released with instructions for field service engineers to replace the fitting on all 3 stainers for all existing and new installations.Roche is currently monitoring the progress of the updates made to the ventana design processes to ensure effective implementation.(b)(4).

• Brand Name: VENTANA HE 600 SYSTEM
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 9311661
• MDR Text Key: 204001378
• Report Number: 2028492-2019-00022
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06917259001
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2028492-10-04-2019-001-C
• Patient Sequence Number: 1