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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that there was a leak.The following information was provided by the initial reporter: wash tower is overflowing.Customer has already tried cleaning the inline filter.

Manufacturer Narrative

H.6 investigation summary: (b)(4).Pn: 647205.Spaiii sn: (b)(6).Awareness: 01/04/2023.Opened: 01/04/2023.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: 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 04jan2022 to date 04jan2023 (rolling 12 months).Complaint trend: there are 10 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 04jan2022 to date 04jan2023 (rolling 12 months).Investigation result / analysis: per fse¿s report: replaced the waste pump and inline filter.Verified instrument performance with the procedure that is provided in the service manual.No further issues.Sample preparation was not affected.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order#: wo - 02785719.Install date: 10sep2009.Defective part number: 640835-spa inline filter kit, 33429709-miniwash assembly.Work order notes: subject / reported: wash tower is overflowing.Problem description: clogged/blocked fluid path.Cause: clogged pump and inline filter.Work performed: replaced pump and inline filter.Solution: replaced pump and inline filter.Parts replaced: 640835-spa inline filter kit, 33429709-miniwash assembly.Returned sample analysis: the defective parts were not requested to be returned and no photo(s) / picture(s) were provided.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes or no? hazard id: 3.1.29.Hazard: environment biohazard.Cause: filter/components in fluid path get clogged, wash station backs up due to waste pump failure.Harmful effects: exposure to biohazard.Residual severity: 5.Residual probability: 1.Residual risk index: 5.Potential causes: based on the investigation result and fse¿s report the potential cause was determined to be wash pump and inline filter.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash tower overflowing.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that there was a leak.The following information was provided by the initial reporter: wash tower is overflowing.Customer has already tried cleaning the inline filter.

• 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
• 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: 16388868
• MDR Text Key: 309950572
• Report Number: 2916837-2023-00040
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K13101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/30/2023
• 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