MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT; SEE H10

Catalog Number 650686

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that during use with a bd facs¿ sample prep assistant the wash tower leaked outside of instrument.The following information was provided by the initial reporter: it was reported that the wash tower was overflowing.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that was leaked? "wash fluid".What is the source of leak? waste line or non-waste line? wash tower 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.Was there spray or fluid under pressure? no.

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.

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is limited to part: 650686 spaiii and serial number: (b)(6).Problem statement: customer reported: wash station is overflowing.Manufacturing defect trend: there are (b)(4) qns related to the reported issue.Date range (date of incident to 12 months back) from 29nov2020 to date 29nov2021 (rolling 12 months).Complaint trend: there are (b)(4) complaints related to the reported complaint.Date range (date of incident to 12 months back) from 29nov2020 to date 29nov2021 (rolling 12 months).Investigation result / analysis: per fse report: replaced wash evacuation pump with a new component, ensure all fittings are secured and that the strainer is clear.No overflow observed during repeated prime cycles.Service max review: review of related work order# (b)(4).Install date: (b)(6) 2005.Defective part number: 334297 ¿ miniwash assembly.Work order notes: subject / reported: wash station is overflowing.Problem description: wash station is overflowing.Cause: wash pump not working.Work performed: replaced wash station pump.Solution: replaced wash station pump.Returned sample evaluation: did not request return of defective pump.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn650686 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 yes no.Root cause: based on the investigation result and the fse¿s report the root cause was a defective waste pump.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station overflow.

Event Description

It was reported that during use with a bd facs¿ sample prep assistant the wash tower leaked outside of instrument.The following information was provided by the initial reporter: it was reported that the wash tower was overflowing.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 was leaked? "wash fluid".4.What is the source of leak -- waste line or non-waste line? wash tower.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.7.Was there spray or fluid under pressure no.

Event Description

It was reported that during use with a bd facs¿ sample prep assistant the wash tower leaked outside of instrument.The following information was provided by the initial reporter: it was reported that the wash tower was overflowing.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 was leaked? "wash fluid" 4.What is the source of leak -- waste line or non-waste line? wash tower 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 7.Was there spray or fluid under pressure no.

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is limited to part: 650686 spaiii and serial number: (b)(4) ¿ problem statement: customer reported: wash station is overflowing ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months) ¿ complaint trend: there are 3 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months) o (b)(4) (this complaint) ¿ investigation result / analysis: per fse report: replaced wash evacuation pump with a new component, ensure all fittings are secured and that the strainer is clear.No overflow observed during repeated prime cycles.¿ service max review: review of related work order# 02223464 install date: 21apr2005 defective part number: 334297 ¿ miniwash assembly work order notes: o subject / reported: wash station is overflowing o problem description: wash station is overflowing o cause: wash pump not working o work performed: replaced wash station pump o solution: replaced wash station pump ¿ returned sample evaluation: did not request return of defective pump ¿ 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: o risk management file part #100245ra, revision 03 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 a defective waste pump ¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station overflow h3 other text : see h.10.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT
• Type of Device: SEE H10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13064766
• MDR Text Key: 284965501
• Report Number: 2916837-2021-00496
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

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 Catalogue Number: 650686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/17/2022; 03/04/2022
• Supplement Dates FDA Received: 02/24/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1