MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR; COUNTER, DIFFERENTIAL CELL

Model Number	342975
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd facscalibur¿ flow cytometer: 4 color produced erroneous ivd results while measuring lymphocytes.There was no adverse patient impact.The following information was provided by the initial reporter, translated from (b)(6): "calibration passed.When measuring lymphocytes, events are shifted onto the axis only at fsc and ssc." "there were air bubbles in the filter.The customer was asked to bleed the filter and clean it with facsclean." are you running patient samples for diagnostic test? - yes.Are there erroneous results on patient samples for diagnostic test? - yes.Was there any delay of treatment due to the issue? - no.If patient samples were redrawn, was there any change or delay of treatment? - no.Was there any physical harm/injury to the patient due to the issue? - no.
Additional 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 or Problem Description
It was reported that the bd facscalibur¿ flow cytometer: 4 color produced erroneous ivd results while measuring lymphocytes.There was no adverse patient impact.The following information was provided by the initial reporter, translated from german: "calibration passed.When measuring lymphocytes, events are shifted onto the axis only at fsc and ssc." "there were air bubbles in the filter.The customer was asked to bleed the filter and clean it with facsclean." "1.Are you running patient samples for diagnostic test? - yes.2.Are there erroneous results on patient samples for diagnostic test? - yes.3.Was there any delay of treatment due to the issue? - no.4.If patient samples were redrawn, was there any change or delay of treatment? - no.5.Was there any physical harm/injury to the patient due to the issue? - no.".
Additional Manufacturer Narrative
H6.Investigation summary: ¿ scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).¿ problem statement: customer reported a complaint regarding the instrument producing erroneous results.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 10mar2021 to date 10mar2022.¿ complaint trend: there are 12 complaints related to the issue of erroneous results.Date range from 10mar2021 to date 10mar2022.¿ manufacturing device history record (dhr) review: dhr part #342975, serial # (b)(6), file # 342975-e97500128-900062276-06, 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 the erroneous results was due to bubbles within a fluidics filter.Bubbles within the sheath filter can lead to time delay issues and flow rate problems, which can contribute to erroneous results.The customer had initially reported that while calibration passed, the events were shifted onto the axis only at fsc and ssc when measuring lymphocytes.The tsr (technical service representative) assisting the customer helped them identify air bubbles within the filter and recommended that the customer vent out the filter and clean it with facsclean.The customer was asked to contact the tsr again if the issue persisted, and as there was no further contact in this case and no cases related to this issue since, the instrument was assumed to be functioning as expected.No parts were requested for evaluation as there were no parts replaced.Although the unexpected results were from patient samples who may be affected by an incorrect analysis of their samples, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnostic decision and these results were easily identified as erroneous.Proper daily and monthly cleaning and maintenance can help maintain an optimal system, and instructions can be found in the file instr for use facscalibur ivd en, #23-12911-02 rev 01/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 #: n/a, case # (b)(4).Install date: 14jun2018.Defective part number: n/a.Case comments: o (3/15/2022 12:42 am) new value: there were air bubbles in the filter.The customer was asked to bleed [empty] the filter and clean it with facsclean.It was agreed with the customer that she would get in touch if the problem recurred.The customer did not contact us, so i assume the device was working properly.O (3/10/2022 1:05 am) there were air bubbles in the filter.The customer was asked to bleed the filter and clean it with facsclean.O (3/10/2022 1:02 am) calibration passed.When measuring lymphocytes, events are shifted onto the axis only at fsc and ssc.¿ returned sample evaluation: a return sample was not requested because there were no replaced parts.¿ risk analysis: risk management file part # 342973-01ra, rev.01/vers.A, bd facscalibur product family risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes or no? o item: sheath filter 80-30038-07.O function: filter sheath.O potential failure mode: time delay errors.O potential effect(s) of failure: erroneous data.O potential cause(s)/mechanism(s) of failure: bubbles in sheath filter.O current controls: facscomp co #1147e500301.O initial severity: 5.O initial occurrence: 3.O initial detection: 5.O rpn: 75.O item: sheath filter 80-30038-07.O function: filter sheath.O potential failure mode: flow rate problems.O potential effect(s) of failure: erroneous data.O potential cause(s)/mechanism(s) of failure: bubbles in sheath filter.O current controls: facscomp co #1147e500301.O initial severity: 5.O initial occurrence: 3.O initial detection: 5.O rpn: 75.Mitigation(s) sufficient: yes or no? ¿ root cause: based on the investigation results the root cause of the erroneous results was due to air bubbles within a fluidics filter.¿ conclusion: based on the investigation results the root cause of the erroneous results was due to air bubbles within a fluidics filter.The assisting tsr helped the customer identify the issue and recommended to vent out the air bubbles and clean it with facsclean.The customer was asked to contact them again if the issue reoccurred, and as there was no second contact or related issues with the instrument since this case, the instrument was assumed to be functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13984247
• Report Number: 2916837-2022-00083
• Device Sequence Number: 5439865
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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
• Operator of Device: Other
• Device Model Number: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown