MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

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

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

Event Date 09/20/2021

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 there were erroneous results while using bd facs lyse wash assistant.These are related to ivd instrument hardware, ivd/asr reagent, and ruo ldt reagent.It is unclear whether the erroneous results were caused from an ruo reagent, or a combination of ivd or ruo reagents, or the instrument.The following information was provided by the initial reporter: as reported code it is mentioned as "result - erroneous diagnostic".Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) yes.Was there any delay of treatment due to the issue? (go to question #3) no.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) no.Provide details - how and to what extent? (go to question #6) the samples were patients samples, but the erroneous tubes have been discarded and prepared again manually.No impact on patients.What is the current medical status? (no further questions required.).

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146 and serial # (b)(6).Problem statement: customer reported a complaint regarding their instrument producing erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2020 to (b)(6) 2021.Complaint trend: there are 6 complaints related to erroneous results; date range from (b)(6) 2020 to (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part #337146, 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 dispensing probe assembly.This assembly handles the measurement and controlled dispense of reagents into samples to prepare them for testing.Failures within this function can lead to improperly prepared samples and subsequent failed tests and erroneous results.The customer had initially reported that the instrument was occasionally not dispensing enough lysant.The fse (field service engineer) confirmed the issue and replaced the assembly probe mechanism (pn 34607219).After installing the part, the fse performed a sample carousel alignment, functionality test, and positive acceptance test.No parts were requested for evaluation as the replaced part was not required for the investigation.After the repair and tests, the instrument was reported to be functioning as expected.Although the unexpected results were from patient samples, the customer confirmed that the erroneous results gathered were not used for the treatment of any patients, and the samples were prepared again manually.There was no delay in treatment, and the patient was not harmed in any way.Proper daily and monthly cleaning procedures can prevent blockages within the fluidics system and maintain instrument health, and can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant system instructions for use, #23-11113-01 rev.1/vers.A, page 111.The safety risk is severe, s4, though 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) 2016.Defective part number: 34607219 - assembly probe mechanism repaired work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - incorrect dispensing of lysant o problem description: the instrument does not dispense the lysant or dispenses a small amount and the stroke is aborted.The problem occurs randomly, sometimes in the first tubes but not always.O work performed: general check of the instrument and diagnosis of the problem.Lysant dispensing unit replacement and sample carousel alignment.Functionality test and positive acceptance test.The instrument works properly within bd's technical specifications.O cause: probe mechanism assy.O solution: none.Returned sample evaluation: a return sample was not requested because while the replaced part is returnable, additional information was not required for the investigation.Risk analysis: risk management file part # ra337408, rev.01/vers.A, bd facs lyse/wash assistant (wa) system hazards analysis report was reviewed.No new hazards have been identified and the current mitigation is sufficient.The severity rating in this file is ¿8d¿ based on the previous scale rating.This rating is equivalent to ¿s4¿ in sop6078-02 rev.12/vers.J, whereby the event may cause erroneous results in testing and/or a significant delay in treatment.The current mitigations are adequate with the risk acceptability as moderate.Hazard(s) identified? yes no o hazard: loss of sample.O target & effect: 1-delayed or no diagnosis, 2-increased cost of test due to the need to reprep and rerun.O cause: n/a.O basic event: 1.3.1.3.1.2 pump to probe.O initial risk: 12d.O risk controls: 1.User's guide: flush dispense before long inactivity.O final risk: 8d.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the erroneous results was due to a worn dispensing probe assembly.Conclusion: based on the investigation results the root cause of the erroneous results was due to a worn dispensing probe assembly.The fse confirmed the issue and replaced the dispensing unit.After installing the part, the fse performed a sample carousel alignment and functionality and positive acceptance tests to confirm that the instrument was functioning within bd¿s technical specifications.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk is severe, s4, though there was no impact to patient health or safety.H3 other text : see h10.

Event Description

It was reported that there were erroneous results while using bd facs lyse wash assistant.These are related to ivd instrument hardware, ivd/asr reagent, and ruo ldt reagent.It is unclear whether the erroneous results were caused from an ruo reagent, or a combination of ivd or ruo reagents, or the instrument.The following information was provided by the initial reporter: as reported code it is mentioned as "result - erroneous diagnostic".1.Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) yes 2.Was there any delay of treatment due to the issue? (go to question #3) no 3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no 4.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) no 5.Provide details - how and to what extent? (go to question #6) the samples were patients samples, but the erroneous tubes have been discarded and prepared again manually.No impact on patients.6.What is the current medical status? (no further questions required.).

• Brand Name: BD FACS LYSE WASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• 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: 12632743
• MDR Text Key: 276618993
• Report Number: 2916837-2021-00397
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• 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: 12/13/2021

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
• Device Operator: Other
• Device Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1