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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

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 prior to reaching the waste line, biohazard leakage occurred when wash station overflowed with a bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: wash station overflowing steps taken with customer/troubleshooting: "customer stated wash station overflowing".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)? no.Additionally, on 2020-06-02 the bd sales consultant provided the following additional information: the tubing connected to the wash tower is discolored and appears to be clogged.She checked the inline filter and it is clean.The instrument has been placed down and out of service.Additionally, on 2020-06-04 the bd sales consultant provided the following additional information: what was the fluid that leaked? unknown.Customer had cleaned area before arrival.Was there spray of fluid under pressure? no if waste/biohazard, did biohazard leak before or after waste line? - before the waste line - the wash station overflowed.If waste/biohazard, was the waste mixed with decontamination or bleach? unknown - customer had cleaned area before arrival.Was the customer/bd personnel physically in contact with the fluid? unknown - customer had cleaned area before arrival.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(4).Problem statement: customer reported that the spa 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 02jun2019 to date 02jun2020 (rolling 12 months).Complaint trend: there are 4 of complaints related to the reported complaint.Date range (date of incident to 12 months back) from 02jun2019 to date 02jun2020 (rolling 12 months) investigation result / analysis: the investigation was performed and based on the fse report verified no issue with waste line/filter.Found the waste pump needed to be cleaned.Ran numerous prime functions without the wash station overflowing.System passed all required tests.Customer ran a sample to verify proper function ¿ passed.No one was exposed to any biological hazards or bodily fluids.¿ service max review: review of related work order #(b)(4).Install date: (b)(6) 2009.Defective part number: there were no defective parts.Work order notes: o subject / reported: wash station overflowing o problem description: wash station was overflowing o cause: waste pump clogged o work performed: cleaned the waste pump o solution: cleaned the waste pump ¿ returned sample evaluation: there were no defective parts.Fse cleaned the waste line, filter and pump.¿ manufacturing device history record (dhr) review: review of the dhr for pn 647205 serial number: (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.This instrument was listed as a prototype ¿ risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? yes no.O hazard id: 3.1.29 o hazard: environmental biohazard.O severity: 5 o probability: 1.O risk index: 5.O implementation: bd facs sample prep user¿s guide.O risk control:alarm.Mitigation(s) sufficient yes no.¿ root cause: based on the investigation result, and the fse¿s report the root cause was the waste pump was clogged ¿ conclusion: based on the investigation results and the fse report the complaint was confirmed h3 other text : see h.10.

Event Description

It was reported that prior to reaching the waste line, biohazard leakage occurred when wash station overflowed with a bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: wash station overflowing steps taken with customer/troubleshooting: "customer stated wash station overflowing" 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)? no.Additionally, on 2020-06-02 the bd sales consultant provided the following additional information: the tubing connected to the wash tower is discolored and appears to be clogged.She checked the inline filter and it is clean.The instrument has been placed down and out of service.Additionally, on 2020-06-04 the bd sales consultant provided the following additional information: what was the fluid that leaked? - unknown - customer had cleaned area before arrival.Was there spray of fluid under pressure? no.If waste/biohazard, did biohazard leak before or after waste line? - before the waste line - the wash station overflowed.If waste/biohazard,, was the waste mixed with decontamination or bleach? unknown - customer had cleaned area before arrival.Was the customer/bd personnel physically in contact with the fluid? unknown - customer had cleaned area before arrival.

• 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: 10180423
• MDR Text Key: 241673588
• Report Number: 2916837-2020-00027
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• 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
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other