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 10/26/2021

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 running the bd facscanto¿ ii flow cytometer carryover occurred due to sit tubing being cracked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that there is high carryover due to the sit tubing being cracked.

Event Description

It was reported that while running the bd facscanto¿ ii flow cytometer carryover occurred due to sit tubing being cracked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that there is high carryover due to the sit tubing being cracked.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2, part #338960, serial # (b)(6).Problem statement: customer reported a complaint regarding high carryover between sample tests.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 26oct2020 to date 26oct2021.Complaint trend: there are 4 similar complaints related to this issue of carryover; date range from 26oct2020 to date 26oct2021.Manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file # (b)(6), 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 carryover between sample tests was due to a worn sit line.The fse (field service engineer) confirmed the issue and replaced the fluidics pump (pn 346340), pressure regulator (pn 65449307), and saline filter (pn 02-61366-00s).They then trimmed the sit tubing at the flowcell input.No return sample was requested for evaluation because the replaced parts are not returnable and were discarded.After the repair, the instrument was tested and performing normally.Although the instrument was used for diagnostic testing the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Cleaning the fluidics and regular maintenance is essential for keeping the instrument at its optimal performance.This information can be found in the bd facscanto¿ ii flow cytometer instructions for use (ifu) manual, #23-20269-00 rev.1/vers.A, starting on page 150.Troubleshooting procedures can be found in the ifu starting on page 181, and page 201 for data issues.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), case # (b)(4).Install date: (b)(6) 2011.Defective part number: 346340 - pump liquid 1/8 barb 65449307 - pressure regulator assembly service 02-61366-00s - saline filter assembly - service work order notes: subject / reported: email states: high carryover.Sit tubing cracked problem description: email states: high carryover.Sit tubing cracked work performed: replaced pump, regulator and filter.Trimmed back sit tubing at input of flowcell.Cause: age solution: tested sit flush functionality and tested carryover with beads.All tests passed.Returned sample evaluation: a return sample was not requested because the replaced parts are not returnable and were discarded.Risk analysis: risk management file part #338960-04ra, version a, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.The severity rating in this file is an ¿9¿ based on the previous scale rating.This rating is equivalent to ¿s3¿ in sop6078-02 rev.12/vers.J, whereby the unexpected result is obvious or indicated by additional (warning) information and hence the impact to the patient is negligible to none.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes, no.Item: 12.Sample introduction tube function: 12.1 retain tube until manually removed potential failure mode: 12.1.1 tube pops off potential effects of failure: 12.1.1.1 biohazard spill potential causes/mechanisms of failure: 12.1.1.1.1 tube seated improperly, tube pressure set too high, or old bal seal does not seal adequately current controls: user observation recommended actions: 1.Lower pressure when not acquiring.2.Service provides spare bal seal to customer, and instructions to replace when any pressure loss is observed sev: 9 occ: 4 det: 2 rpn: 72 mitigation(s) sufficient yes, no.Root cause: based on the investigation results the root cause of the carryover was due to an old sit line.Conclusion: based on the investigation results the root cause of the carryover was due to an old sit line.The fse confirmed the issue and replaced the pump, regulator, and filter.They then trimmed the tubing connected to the flowcell.After the repairs the instrument was tested and functioning as expected.No treatment or diagnosis was given due to the unexpected results.The safety risk is moderate, s3, and there was no impact to 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12844882
• MDR Text Key: 281854639
• Report Number: 2916837-2021-00451
• 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,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: 03/11/2022
• 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