MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number 338960

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that during use with a bd facscanto¿ ii flow cytometer the waste line leaked outside of the instrument.The following information was provided by the initial reporter: it was reported that the instrument is leaking.The customer stated that the tech wore gloves when they cleaned up the leak and that they were not exposed to the fluid nor were they harmed as a result of the leak.Customer has put the instrument down and out of service.Is instrument assurity linc enabled? n.Customer problem: wet cart is leaking.Steps taken with customer/troubleshooting: "called customer back.The wet cart is leaking.There was a puddle on the floor under the wet cart.Customer suspects that it is waste as it appears that the only fluid that is in the waste tank is the bleach that they had put into it.Customer opened the wet cart and observed that the filter inside of the door was wet and the p7 on the valve manifold has salt buildup around it.The customer stated that the tech wore gloves when they cleaned up the leak and that they were not exposed to the fluid nor were they harmed as a result of the leak." next steps (if necessary): dispatch.Are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.Leak (if yes explain)? y, leak inside of the wet cart.Was the leak contained within the instrument? no, the fluid leaked onto the floor.Was the leak in a customer accessible location? no, inside of wet cart.What was the fluid that leaked? suspect waste.What is the source of leak -- waste line or non-waste line? waste.Was the customer exposed to blood or bodily fluids? n.Was there any physical harm to the customer as a result of the leak? n.Software version? unknown.Resolution achieved (y/n)? n.Follow up required (y/n)? y.List of parts shipped (include foc): n/a.Rma required (y/n)? n/a.

Manufacturer Narrative

H6: investigation summary: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax the root cause of waste leakage, without bleach, not contained within the wet cart was due to a worn check valve.Upon arrival, the fse (field service engineer) had confirmed the source of the leak at part# 334044 - check valve waste.He replaced the part, cleaned the wet cart with 10% bleach solution and ran a 7-color setup bead test.After the repair, the instrument was tested and was performing normally.The replaced part was not requested for evaluation as it is not returnable.Based on the investigation results, the root cause of waste leaking from the facscanto ii instrument wet cart was due to a bad waste check valve, part #334044.The fse confirmed the issue and replaced the part.It was also confirmed that there was no fluid under any pressure.The leak was cleaned up with bleach solution along with proper ppe and caution.After the repair, the instrument was rebooted, tested, and functioning as expected.The safety risk is low as there was no impact to customer health or safety.H3 other text : see h.10.

Event Description

It was reported that during use with a bd facscanto¿ ii flow cytometer the waste line leaked outside of the instrument.The following information was provided by the initial reporter: it was reported that the instrument is leaking.The customer stated that the tech wore gloves when they cleaned up the leak and that they were not exposed to the fluid nor were they harmed as a result of the leak.Customer has put the instrument down and out of service.Is instrument assurity linc enabled? n.Customer problem: wet cart is leaking steps taken with customer/troubleshooting: "called customer back.The wet cart is leaking.There was a puddle on the floor under the wet cart.Customer suspects that it is waste as it appears that the only fluid that is in the waste tank is the bleach that they had put into it.Customer opened the wet cart and observed that the filter inside of the door was wet and the p7 on the valve manifold has salt buildup around it.The customer stated that the tech wore gloves when they cleaned up the leak and that they were not exposed to the fluid nor were they harmed as a result of the leak." next steps (if necessary): dispatch are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.Leak (if yes explain)? y, leak inside of the wet cart.1.Was the leak contained within the instrument? no, the fluid leaked onto the floor.2.Was the leak in a customer accessible location? no, inside of wet cart.3.What was the fluid that leaked? suspect waste.4.What is the source of leak -- waste line or non-waste line? waste.5.Was the customer exposed to blood or bodily fluids? n.6.Was there any physical harm to the customer as a result of the leak n.Software version? unknown.Resolution achieved (y/n)? n.Follow up required (y/n)? y.List of parts shipped (include foc): n/a.Rma required (y/n)? n/a.

• Brand Name: BD FACSCANTO II FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10638431
• MDR Text Key: 238137035
• Report Number: 2916837-2020-00155
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 0382903389605
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other