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 Contamination (1120)

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

Event Date 10/22/2021

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 facs¿ lyse wash assistant carried over contamination between samples.There was no adverse patient impact.The following information was provided by the initial reporter: "customer suspects a contamination between samples that is observable when acquiring tubes with the facscanto.The cytometer is clean and cst passes fine." were samples contaminated? yes.Are there erroneous results on patient samples for diagnostic test? no.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.

Event Description

It was reported that the bd facs¿ lyse wash assistant carried over contamination between samples.There was no adverse patient impact.The following information was provided by the initial reporter: "customer suspects a contamination between samples that is observable when acquiring tubes with the facscanto.The cytometer is clean and cst passes fine." were samples contaminated? yes.Are there erroneous results on patient samples for diagnostic test? no.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

H.6.Investigation: ¿ 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 sample carryover.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 22oct2020 to 22oct2021.¿ complaint trend: there are 11 complaints related to the issue of sample carryover.Date range from 22oct2020 to 22oct2021.¿ 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 carryover between sample tests could not be determined.The customer had initially reported that they observed carryover between sample tests.The fse (field service engineer) that came onsite responding to the complaint ran several tests with the customer to observe the carryover, but the instrument was functioning as expected with no erroneous results.No parts were requested for evaluation as there were no parts replaced.Although the unexpected results were from patient samples, no patient was treated nor harmed from incorrect 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 reducing the chance of carryover, 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 moderate, s3, and there was no impact to patient health or safety.¿ service max review: review of related work order #: 02168973, case # (b)(4).Install date: 28mar2019.Defective part number: n/a.Work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - carryover.O problem description: customer suspects a carryover between samples.When acquiring tubes with the cytometer, they see populations from the previous tubes.O work performed: lwa compliant.O cause: lwa.O solution: after several tests carried out with the client, everything seems normal to me.Support requested from the application service.¿ returned sample evaluation: a return sample was not requested because there were no parts replaced.¿ risk analysis: risk management file part # 337146ra, rev.02/vers.C, bd facs¿ lyse/wash assistant risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes or no.O id: (b)(6).O hazard: carryover.O cause: clogged orifice.O harmful effects: incorrect results, damaged instrument.O risk control: replace orifice at each pm interval.O implementation verification: reliability testing in sv lab; protocol: gppd0010-03 rev a.O effectiveness verification: system characterization summary report lwa carryover evaluation phase iii version 1.0 10/mar/2010.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient: yes or no? ¿ root cause: based on the investigation results the root cause of the carryover between samples could not be determined.¿ conclusion: based on the investigation results the root cause of the carryover between samples could not be determined.After receiving the customer complaint, an fse came onsite to confirm the issue.After running several tests with the customer, the fse determined that the instrument was functioning as expected with no erroneous results.No one was harmed or injured, and no medical diagnosis was performed due to the initial erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.

• 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: 12835820
• MDR Text Key: 280954292
• Report Number: 2916837-2021-00445
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/05/2022

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
• 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: 10/22/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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