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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.Medical device expiration date: unknown.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 bd facs¿ sample prep assistant iii waste leaked outside of instrument.There was no impact to patient.The following information was provided by the initial reporter: it was reported that there is a wash station overflow.Steps taken with customer/troubleshooting: cts to troubleshoot.Next steps (if necessary): forward case to cts for troubleshooting are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? yes.Wash station overflowed.No pressure or spray.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak -- waste line or non-waste line? waste.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii waste leaked outside of instrument.There was no impact to patient.The following information was provided by the initial reporter: it was reported that there is a wash station overflow.Steps taken with customer/troubleshooting: cts to troubleshoot next steps (if necessary): forward case to cts for troubleshooting are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? yes.Wash station overflowed.No pressure or spray.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.What was the fluid that leaked? 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? no.6.Was there any physical harm to the customer as a result of the leak no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaii and serial number: (b)(6).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 27oct2019 to date 27oct2020 (rolling 12 months).Complaint trend: there are 2 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 27oct2019 to date 27oct2020 (rolling 12 months).Investigation result / analysis: per fse report: flushed the waste line filter fittings and wash pump.One of the fittings was still partially clogged and unable to be flushed: it was replaced.The instrument was then initialized and primed multiple times to confirm proper aspiration of the wash tower.Flushing the waste line and replacing the clogged components resolved the reported issue.The instrument is operating as intended and is testing without errors.The instrument has been returned to the lab for normal use.Service max review: review of related work order #01662396.Install date: defective part number: there were no defective parts work order notes: subject / reported: wash tower overflowing.Problem description: wash tower overflow.Cause: clogged lines work performed: flushed the waste line.Solution: flushed the waste line.Returned sample evaluation: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? yes no.Hazard id: 3.1.29.Hazard: environmental biohazard severity: 5.Probability: 1 risk index: 5.Implementation: bd facs sample prep user¿s guide.Risk control:alarp.Mitigation(s) sufficient no.Root cause: based on the investigation result, and the fse¿s report the root cause was clogged waste line.Conclusion: based on the investigation results and the fse report the complaint was confirmed for the wash tower overflow.H3 other text : 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: 10844261
• MDR Text Key: 216386524
• Report Number: 2916837-2020-00254
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• 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: 07/01/2021

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: 10/27/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1