MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT III; SEE H.10

Model Number 647205

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.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 while using a bd facs¿ sample prep assistant iii sheath in the waste line leaked outside of instrument.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the wash tower is overflowing.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Software version? unknown.Leak (if yes explain)? yes.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? sheath.What is the source of leak, waste line, or non-waste line? waste line.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Was the fluid spraying out from the point of the leak? no.Was the waste mixed with decontamination / bleach solution? no.

Event Description

It was reported that while using a bd facs¿ sample prep assistant iii sheath in the waste line leaked outside of instrument.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the wash tower is overflowing.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Software version? unknown.Leak (if yes explain)? yes.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? sheath.What is the source of leak -- waste line or non-waste line? waste line.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.Was the fluid spraying out from the point of the leak? no.Was the waste mixed with decontamination / bleach solution? no.

Manufacturer Narrative

H.6.Investigation: ¿ problem statement: customer reported that the wash tower is overflowing ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 13oct2019 to date 13oct2020 (rolling 12 months) ¿ complaint trend:there are 8 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 13oct2019 to date 13oct2020 (rolling 12 months) ¿ investigation result / analysis: per fse report: found quick disconnect fitting to waste filter were clogged.Replaced quick disconnect fittings.Ran sampler and lyse dispense checks and did not see any overflow from wash station.No one was exposed to any biohazard.System is performing as expected.¿ service max review: review of related work order #01644616 install date: 19apr2010 defective part number: there were no defective parts work order notes: o subject / reported: wash tower overflowing o problem description: wash tower overflow o cause: cannot duplicate initialization error.Clogged fitting caused overflow o work performed: replaced fittings o solution: replaced fittings ¿ returned sample evaluation: there were no defective parts ¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #100245ra, revision 02 was reviewed.O hazard(s) identified? yes no hazard id: 3.1.29 _ hazard: environmental biohazard severity: 5 probability: 1 risk index: 5 o implementation: bd facs sample prep user¿s guide__ o risk control:_alarp_____ o mitigation(s) sufficient yes no ¿ root cause: based on the investigation result, and the fse¿s report the root cause was clogged fitting caused the wash tower to overflow.¿ conclusion: based on the investigation results and the fse report the complaint was confirmed for the wash tower overflow.See h.10.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10773333
• MDR Text Key: 214379367
• Report Number: 2916837-2020-00224
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1