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

Model Number 338960

Device Problem Contamination (1120)

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

Event Date 04/27/2021

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.

Event Description

It was reported that while using bd facscanto ii flow cytometer the tubing in wetcart was discovered to be contaminated.There was no report of patient impact.The following information was provided by the initial reporter: contaminated facsclean tubing in wetcart.

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer the tubing in wetcart was discovered to be contaminated.There was no report of patient impact.The following information was provided by the initial reporter: contaminated facsclean tubing in wetcart.

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd part # 338960, serial # (b)(6).Problem statement: customer reported complaint of a contaminated facsclean tubing line in the wetcart.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 17jul2019 to date 17jul2020.Complaint trend: this is the only complaint related to the complaint of a contaminated facsclean tubing line in the wetcart.Date range from 17jul2019 to date 17jul2020.Manufacturing device history record (dhr) review: dhr part #338960 serial (b)(6) , file # 338961-v96100087-900082215-06, 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 contaminated facsclean tubing and the sheath input line could not be determined.This is the only complaint in the previous 12 months from the incident.A possible cause could be from salt crystal build up from sheath fluid if the instrument is not properly shutdown or started and maintained.The fse (field service engineer) observed the issue and replaced the facsclean tubing in the wetcart and the sheath input line to the flow cell.This service was performed under the same servicemax visit, wo-01884915, case-01324075, for related complaint, pr# (b)(4).There was no harm caused to anyone since no fluids came into contact the user(s).Also no patient samples were affected by this issue and no diagnosis or treatment was given to incorrect results.No parts were requested for evaluation as the replaced tubing is not returnable and was discarded.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is low as there was no impact to customer and patient health or safety.Service max review: review of related work order #: 01884915, case # (b)(4) (from related complaint pr# (b)(4) ) install date: 04oct2006.Defective part number: n/a.Work order notes: subject / reported: blue laser intermittently turning off.Problem description: blue laser intermittently turning off.He says tube depressurizes, laser power goes to zero and it then turns off.He does a visual check on the laser and he can see its off.This has happened 7-8 times in the past two weeks.He says the laser power and current will be low and the measured values are zero.Work performed: inspected and installed blue laser.Verified part is functional.Optimized laser optical alignment, verified instrument specs, and verified instrument performance unrelated problem: contaminated facsclean tubing in wetcart and sheath input tubing to flowcell.Replaced tubing in wetcart & flowcell (parts provided from customer's spare parts), cleaned wetcart internally & externally.Cause: 1.Faulty blue laser 2.Contaminated tubing.Solution: replacing blue laser resolved the issue.Verified instrument is operational with passing performance results.Returned sample evaluation: a return sample was not requested because no parts were replaced.Risk analysis: risk management file part # 338960-04ra, rev.A, bd facscanto ii flow cytometer (fluidics) was reviewed.The severity rating in this file is ¿5¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby the damage to the device is obvious and is reparable by requiring a service visit.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes, no? item: 23.Valves.Function: 23.1 block, pass, or direct fluids.Potential failure mode: 23.1.1 valve leaks.Potential effects of failure: 23.1.1.1 fluidics mode operates incorrectly, degradation of performance.Potential causes/mechanisms of failure: 23.1.1.1.1 stuck valve or debris or saline buildup.Current controls: di rinse daily.Recommended actions: n/a.Responsible party: n/a.Target completion date: n/a.Actions taken: n/a.Sev: 5.Occ: 7.Det: 1.Rpn: 35.Mitigation(s) sufficient: yes, no? root cause: based on the investigation results the root cause could not be determined.Conclusion: based on the investigation results, the root cause of contamination in the facsclean tubing in the wet cart and near flow cell could not be determined.The fse noticed the issue, replaced all the tubing in question, and brought the instrument to normal operation.No one was harmed or injured, and no medical treatment was needed.No erroneous were used for diagnosis or treatment from the contamination.The safety risk is low and there was no impact to customer and patient health or safety.H3 other text : see h10.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11843179
• MDR Text Key: 252243962
• Report Number: 2916837-2021-00243
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062087
• 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
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• 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