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 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd facscanto¿ ii flow cytometer was carrying over patient samples.The following information was provided by the initial reporter: "the equipment shows carryover.Are there erroneous results on patient samples for diagnostic test? no.".

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, and serial # (b)(6).Problem statement: customer reported a complaint regarding their instrument producing high carryover.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 29dec2020 to date 29dec2021.Complaint trend: there are 4 complaints related to the issue of carryover; (b)(6).Date range from (b)(6)2020 to date (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part # 338960 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 carryover between samples was due to a clogged aspirator line.The customer had initially reported that the aspirator arm was clogged, and fluid would leak during the sit flush without being cleared.An fse (field service engineer) came onsite for the repair, inspected the instrument, and identified the clog.They then removed the waste line tubing and connectors from the aspirator arm and cleaned them.After the cleaning, the fluid carriage suction pump was tested and confirmed to be functional and customer samples passed without issue.The instrument was then tested with rb and cst calibration beads, which passed, and the instrument was functioning as expected.No parts were requested for evaluation as there were no replaced parts.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 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.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2014.Defective part number: n/a.Work order notes: subject / reported: 338960 - bd facscanto ii cytometer 4/2 system ivd problem description: the vacuum in the arm is clogged and during the sit flush the liquid runs out.The equipment features carryover.Work performed: check the operation of the equipment.Remove the waste line tube and connectors from the vacuum arm and clean.Check operation of the fluid carriage suction pump.Pass customer samples, ok.Pass rb and cst calibration beads, ok.The equipment remains working properly.Cause: aspiration sit flush.Solution: clean suction circuit.Returned sample evaluation: a return sample was not requested because there were no replaced parts.Risk analysis: a review of the bd facscanto ii flow cytometer (fluidics) fmea #338960-04ra (version a/revision 1) has identified the hazard of carryover.These risks contains the appropriate mitigations and have safety risks within acceptable levels.Hazard(s) identified? yes, no.Item: 10.Sit id/od flush; function: 10.1 clean sit id/od, reduce carryover; potential failure mode: 10.1.2 saline drop hangs on end of sit after purge cycle; potential effects of failure: 10.1.2.1 drop falls on user's hand; potential causes/mechanisms of failure: 10.1.2.1.1 drop stuck to sit; current controls: 1.Aspirator arm bar.2.User training; recommended actions: n/a; responsible party: n/a; target completion date: n/a; actions taken: n/a; sev: 1; occ: 6; det: 2; rpn: 12.Mitigation(s) sufficient ? yes ,no.Root cause: based on the investigation results the root cause of the carryover was due to a clogged aspirator tubing.Conclusion: based on the investigation results the root cause of the carryover was due to a clogged aspirator tubing.The fse confirmed the issue and removed the waste line tubing and connectors of the aspirator arm for cleaning.After reinstalling these parts, the instrument was tested and functioning as expected.No treatment or diagnosis was given due to the unexpected results.The safety risk of this hazard has been identified to be within the acceptable level.

Event Description

It was reported that bd facscanto¿ ii flow cytometer was carrying over patient samples.The following information was provided by the initial reporter: "the equipment shows carryover.1.Are there erroneous results on patient samples for diagnostic test? no".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13155679
• MDR Text Key: 283611365
• Report Number: 2916837-2021-00515
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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