MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR; COUNTER, DIFFERENTIAL CELL

Model Number 342975

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/29/2021

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 the bd facscalibur¿ flow cytometer: 4 color produced erroneous ivd results.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of adverse patient impact.The following information was provided by the initial reporter, translated from spanish: "result - erroneous diagnostic." "are there erroneous results on patient samples from 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.".

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 29nov2020 to date 29nov2021.Complaint trend: there are 9 complaints related to the issue of erroneous results; date range from 29nov2020 to date 29nov2021.Manufacturing device history record (dhr) review: dhr part #342975 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 erroneous results was due to a worn dcm line.The customer had initially reported that their instrument was producing erroneous results and the sample was occasionally disappearing.The fse (field service engineer) that came onsite found that the sample was leaking down the dcm tubing and replaced the dcm tubing.They then replaced the sample needle¿s o-ring and tested the instrument to verify proper sample acquisition.No parts were requested for evaluation as the replaced part is not returnable and was discarded.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.The safety risk is limited, s2, 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) 2012 defective part number: 343585 - tubing neoprene dcm, 343509 - bal seal (sip) work order notes: subject / reported: randomly the whole sample goes.Problem description: randomly the whole sample goes.Work performed: peristaltic pump system control.Replacement of the hose in the dcm, control of the adjustment of the hose, replacement of the o-ring in the sampling needle.Proof of acquisition.Cause: the sample was leaking down the dcm line.Solution: several acquisition tests were carried out.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 # (b)(4), rev.01/vers.A, risk analysis facscalibur 3 color basic ivd was reviewed.No new hazards have been identified and the current mitigation is sufficient.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 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.Hazard(s) identified? yes/no item: sheath filter 80-30038-07 function: filter sheath potential failure mode: caught at installation potential effect(s) of failure: caught at installation potential cause(s)/mechanism(s) of failure: fitting problem current controls: facscomp co #1147e500301 severity: 5 occurrence: 3 detection: 3 rpn: 45 mitigation(s) sufficient yes/no root cause: based on the investigation results the root cause of the erroneous results was due to a worn dcm line.Conclusion: based on the investigation results the root cause of the erroneous results was due to a worn dcm line.The fse confirmed the issue and replaced the dcm hose.They then replaced the o-ring for the sit needle and confirmed that the instrument was functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk is limited, s2, and there was no impact to patient health or safety.

Event Description

It was reported that the bd facscalibur¿ flow cytometer: 4 color produced erroneous ivd results.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of adverse patient impact.The following information was provided by the initial reporter, translated from spanish: "result - erroneous diagnostic.Are there erroneous results on patient samples from 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.".

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR
• 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: 13080563
• MDR Text Key: 285061800
• Report Number: 2916837-2021-00500
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K973483
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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