MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number 342975

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

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 while using bd facscalibur¿ flow cytometer results were reading high.There was no reported patient impact.The following information was provided by the initial reporter, "samples reading high.".

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, and serial # (b)(6).Problem statement: customer reported complaint on their instrument producing high sample readings.Manufacturing defect trend: there are 0 qns (quality notifications) related to erroneous results for this part within this date range.Date range from 22oct2019 to date 22oct2020.Complaint trend: there are 4 complaints related to the issue of erroneous results.Date range from 22oct2019 to date 22oct2020.Manufacturing device history record (dhr) review: dhr part #342975 serial # (b)(6), file #(b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the high sample readings was misaligned optics.An fse (field service engineer) was dispatched to the customer and confirmed the issue.They then proceeded to align the optics and run controls on the instrument.After the repair, the instrument was rebooted, tested and functioning as expected.No parts were requested for evaluation as there were no damaged or replaced parts.A possible cause of the misaligned optics is mechanical stress on the laser cover.The design on the cover did not account for fan cooling ducting geometry, and this expansion and contraction cause flexing on the optical deck (reference service bulletin fcb 07-01), as seen in the below risk section.Another potential cause for this misalignment is that the lens was built improperly or the optics were misaligned incorrectly.Although unexpected results are a critical issue that can be dangerous if used in a diagnosis, no patient was treated nor harmed from these erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.Service max review: review of related work order #:(b)(4) install date: 12mar2014 defective part number: n/a work order notes: subject / reported: samples reading high, problem description: samples reading high, work performed: aligned optics and ran controls, cause: samples reading high, solution: working fine returned sample evaluation: a return sample was not requested because no parts were replaced or repaired.Risk analysis: risk management file part # 342973ra, rev.04/vers.D, bd facscalibur product family risk analysis and file part #ra342973-01, rev.A, bd facscalibur fmea were reviewed and potential causes to the issue were listed below.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no 342973ra id: 1.4.2 hazard: mechanical stress affecting optical alignment cause: mechanical interference plastic top cover did not account for fan cooling ducting geometry, causing flexing the optical deck reference service bulletin (fcb 07-01) harmful effects: this affected the laser alignment and performance when cover is closed a s instructed.May not pass facscomp on 4 color instruments risk control: initiated rework to internal units already built initiated rework at supplier tool was modified to eliminate the mechanical stress for fan req link (tfs id): implementation verification: libivd-se-15-84ar cuvette cleanliness protocol lsv1004-dp co implemented to correct tool for required notch bulletin issued to fse base effectiveness verification: co# 1147e502426 fcb 07-01 probability: 1 severity: 3 risk index: 3 residual risk evaluation: a new hazards: none ra342973-01 item: focus lens in collection optics potential failure mode: lack of sensitivity potential effect(s) of failure: erroneous data potential cause(s)/mechanism(s) of failure: lens assembled wrong current controls: car #185, co #45307 - oms 341660 rpn: 45 severity: n/a occurrence: n/a detection: n/a mitigation(s) sufficient yes.No.Root cause: based on the investigation results the root cause was due to misaligned optics.Conclusion: based on the investigation results, the root cause of the customer observing high sample readings was from misaligned optics.The fse confirmed the issue and performed a repair by aligning optics and running controls on the instrument.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured due to this incident, and no medical diagnosis was performed due to the erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.H3 other text : see h.10.

Event Description

It was reported that while using bd facscalibur¿ flow cytometer results were reading high.There was no reported patient impact.The following information was provided by the initial reporter: samples reading high.

• Brand Name: BD FACSCALIBUR FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10829960
• MDR Text Key: 216196584
• Report Number: 2916837-2020-00244
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• PMA/PMN Number: K923790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/12/2020
• 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