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

Model Number 338960

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/26/2021

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 while running patient samples on bd facscanto¿ ii flow cytometer carryover of the sample occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: cytometer does not flush sit well and there is carryover between samples.

Event Description

It was reported while running patient samples on bd facscanto¿ ii flow cytometer carryover of the sample occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: cytometer does not flush sit well and there is carryover between samples.

Manufacturer Narrative

H6: 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 a complaint regarding observed sample carryover.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 30jul2020 to date 30jul2021.Complaint trend: there are 2 complaints related to the issue of sample carryover; date range from 30jul2020 to date 30jul2021.Manufacturing device history record (dhr) review: dhr part #338960 serial # (b)(6), file # 338961-v96101117-900207251-09, 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 sample carryover was due to a dirty fluidics system.Dirt, clogs, and foreign matter within the fluidics system can interfere with tests run on patient samples and may lead to erroneous results, carryover, or leakages.The customer had initially submitted a complaint detailing that the instrument was not running the sit flush operation properly, and that they had observed carryover between sample tests.A tsr (technical service representative) assisted the customer during a phone consultation, and instructed the customer to run diluted contrad through the system overnight.The next day the customer reported that the instrument was running properly with no signs of carryover.No parts were requested for evaluation as there were no parts replaced.Although the unexpected results were from patient samples, no patient was harmed or affected from the erroneous results.The results were captured prior to any diagnosis decision and was reported to bd as not expected.Proper daily and monthly cleaning procedures¿may help in clearing up clogs and preventing carryover, and¿can be found under ¿maintenance¿ in the user guide; bd¿facscanto¿ ii flow cytometer instructions for use, #23-20269-00 rev.1/vers.A, page 149.The safety risk is limited, s2, and there was no impact to patient health or safety.Service max review: review of related work order #: 02044080, case # (b)(4).Install date: 24jul2019.Defective part number: n/a.Work order notes: subject / reported: 338960 - bd facscanto ii cytometer 4/2 system ivd - drag between samples.Problem description: cytometer does not flush sit well and there is carryover between samples.Work performed: telephone solution.Customer is instructed to put contrad diluted overnight.In the following days no anomalies are observed.Verification of satisfactory operation.Cause: dirt.Solution: telephone solution.Customer is instructed to put contrad diluted overnight.In the following days no anomalies are observed.Verification of satisfactory operation.Returned sample evaluation: a return sample was not requested because there were no parts 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 ¿8¿ 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: 10.Sit id/od flush, function: 10.1 clean sit id/od reduce carryover, potential failure mode: 10.1.3 id not cleaned, potential effects of failure: 10.1.3.1 excessive carryover, wrong results, potential causes/mechanisms of failure: 10.1.3.1.1 software crashes, leaving tube on sit ¿ flush never occurs.Current controls: n/a.Recommended actions: 1.Add id/od flush to fluidics startup.2.Add id/od flush menu item.Actions taken: 1.Id/od flush was added to the fluidics startup workflow2.Heat100012152 (work complete 9/28/05) & nexus00002057 (closed 10/2/05) diva added sit flush menu (heat100011820 closed 9/30/05) severity: 8.Occurrence: 1.Detection: 8.Rpn: 64.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the sample carryover was due to a dirty fluidics system.Conclusion: based on the investigation results the root cause of the sample carryover was due to a dirty fluidics system.The customer submitted a complaint regarding carryover between samples and their instrument not performing the sit flush properly.During a phone consultation, the tsr instructed the customer to run diluted contrad through the system, and the following day the customer reported that the instrument was performing as expected.No one was harmed or injured, and no medical treatment was performed due to the erroneous results.The safety risk is limited, s2, 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: 12358777
• MDR Text Key: 267837739
• Report Number: 2916837-2021-00349
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 11/04/2021
• 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