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

Model Number 647205

Device Problem Contamination (1120)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "it was reported by the customer that it is not rinsing probe between samples causing obvious carryover is instrument assurity link n.Customer problem: it is not rinsing probe between samples.Steps taken with customer/ troubleshooting: it is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.I asked her to change the probe and clean the in-line filter, she told me she would not do any of that.She explained the engineer normally comes on mondays and she would just like it dispatched.Next steps (if necessary): fse dispatch are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.Leak (if yes fill out check list)? n.Resolution achieved? n.Follow up required? y.It is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.".

Manufacturer Narrative

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

Manufacturer Narrative

The following information from the investigation has been corrected: changed from: "it was reported by the customer that it is not rinsing probe between samples causing obvious carryover." changed to: "1.Were samples contaminated? 2.Are there erroneous results on patient samples for diagnostic test? 1.I do not think so, in retrospect nothing was added to the samples they were just not properly preped.2.Yes.".

Event Description

It was reported that while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "it was reported by the customer that it is not rinsing probe between samples causing obvious carryover.Is instrument assurity link n.Customer problem: it is not rinsing probe between samples.Steps taken with customer/ troubleshooting: it is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.I asked her to change the probe and clean the in-line filter, she told me she would not do any of that.She explained the engineer normally comes on mondays and she would just like it dispatched.Next steps (if necessary): fse dispatch are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.Leak (if yes fill out check list)? n.Resolution achieved? n.Follow up required? y.It is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.Additional information: there is new information on the patient samples.Please see below: 1.Were samples contaminated? 2.Are there erroneous results on patient samples for diagnostic test? 3.Was there any delay of treatment due to the issue? 4.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4).5.Was there any physical harm/injury to the patient due to the issue? 1.I do not think so, in retrospect nothing was added to the samples they were just not properly preped.2.Yes.3.Yes but briefly as they have other systems they can use.4.No redraw.I have no information for the other questions.".

Manufacturer Narrative

The following fields have been updated with additional information: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 30-may-2022.H.2 device return to manuf.?: no.H.2 device eval by manufacturer?: yes.The following information from the investigation has been updated: investigation gc re-opened because return sample evaluation needs update to state defective part is valve and the as analyzed component code needs to be updated to valve - liquid.Update from: returned sample evaluation: there was no defective part reported to: returned sample evaluation: the defect part was not requested.Clogged valve from pm kit was replaced.As analyzed component: probe / syringe assembly.To: as analyzed component: valve - liquid.(b)(4).Pn: 647205.Spaiii.Sn: (b)(6).Date reported: 05/16/2022.Investigation summary: ¿ scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).¿ problem statement: customer reported: probe not rinsing causes carry over ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 16may2021 to date 16may2022 (rolling 12 months) ¿ complaint trend: there are 3 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 16may2021 to date 16may2022 (rolling 12 months).O (b)(4) (this complaint).¿ investigation result / analysis: per fse report: customer reported that the washing/rinsing of the probe is not effective.This is causing a carryover condition affecting sample preparation.There was brief delay in sample analysis.The sample analysis was performed on another system.Fluidic connector valve was found to be clogged.Valve from customers pm kit was used to replace the clogged valve.Verified system performance by successfully priming all air from the system and running 6 tubes with no carry over.¿ service max review: review of related work order# 02451182.Install date: (b)(6) 2012.Defective part number: not reported.Work order notes: o subject / reported: probe not rinsing causes carry over.O problem description: carry over.O cause: clogged connector valve.O work performed: replaced connector valve.O solution: replaced connector valve.¿ returned sample evaluation: did not request return of defective part.Clogged valve from pm kit was replaced.¿ 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: o risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? yes or no? o hazard id: 3.1.2.O hazard: sample carryover (flat tip probe).O severity: 2.O probability: 2.O risk index: 4.O implementation: bd facs sample prep user¿s guide.O risk control: acceptable.O mitigation(s) sufficient: yes or no? risk analysis: a.Risk management file part #100245ra, revision 03 was reviewed.B.Hazard(s) identified? yes or no? i.Hazard id: 3.1.1.Ii.Hazard: sample carryover (flat tip probe).1.Cause: insufficient washing between samples.2.Harmful effects: incorrect or no result.Iii.Severity: 2.Iv.Probability: 2.V.Risk index: 4.C.Implementation: bd facs sample prep user¿s guide.D.Risk control: acceptable.E.Mitigation(s) sufficient: yes or no? risk analysis: a.Risk management file part #100245ra, revision 03 was reviewed.B.Hazard(s) identified? yes or no? i.Hazard id: 3.1.13.Ii.Hazard: improper sample mixing.1.Cause: incorrect mixing profile.2.Harmful effects: a.Improperly prepared sample.B.Loss of sample.C.Delayed results.Iii.Severity: 3.Iv.Probability: 1.V.Risk index: 3.C.Implementation: bd facs sample prep user¿s guide.D.Risk control: acceptable.E.Mitigation(s) sufficient: yes or no? ¿ root cause: based on the investigation result and the fse¿s report the root cause was a clogged connector valve ¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for probe not rinsing causing carryover.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is limited and there was no impact to the patient health or safety.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "it was reported by the customer that it is not rinsing probe between samples causing obvious carryover is instrument assurity link: n.Customer problem: it is not rinsing probe between samples.Steps taken with customer/ troubleshooting: it is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.I asked her to change the probe and clean the in-line filter, she told me she would not do any of that.She explained the engineer normally comes on mondays and she would just like it dispatched.Next steps (if necessary): fse dispatch.Are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.Leak (if yes fill out check list)? n.Resolution achieved? n.Follow up required? y.It is not rinsing probe between samples.They ran a blank tube and there was obvious carry over.Additional information: there is new information on the patient samples.Please see below: 1.Were samples contaminated? 2.Are there erroneous results on patient samples for diagnostic test? 3.Was there any delay of treatment due to the issue? 4.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4).5.Was there any physical harm/injury to the patient due to the issue? 1.I do not think so, in retrospect nothing was added to the samples they were just not properly preped.2.Yes.3.Yes but briefly as they have other systems they can use.4.No redraw.I have no information for the other questions.".

• 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: 14519423
• MDR Text Key: 293550241
• Report Number: 2916837-2022-00137
• 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: K131301
• 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: 07/12/2022

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/21/2022; 07/12/2022
• Supplement Dates FDA Received: 07/15/2022; 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• 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