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 10/21/2021

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 report of 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 patient samples involved? yes.Is a confirmatory test always performed? yes.Was it obvious that the results could not be trusted? yes.Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.

Manufacturer Narrative

H6: 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 sample carryover.Manufacturing defect trend: there are (b)(4) 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 customer observing carryover could not be determined.The customer reported that they suspected contamination between samples during tube acquisition with the facscanto.They also reported that the cytometer was clean and the cst passed without issue.An fse was brought onsite to observe the issue and they ran several tests with the customer.After testing, no issues were observed and the instrument seemed 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, 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 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 #: (b)(4), case # (b)(4).Install date: (b)(6) 2014.Defective part number: n/a.Work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - possible carry over.O problem description: customer suspects a contamination between samples that is observable when acquiring tubes with the facscanto.The cytometer is clean and cst passes fine.O work performed: tests on several tubes the lwa are 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 no.O id: 2.1.1.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 no.Root cause: based on the investigation results the root cause of the sample carryover could not be determined.Conclusion: based on the investigation results the root cause of the sample carryover could not be determined.The fse ran several tests with the customer and was unable to find any issues with the instrument or samples, and thus reported 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 moderate, s3, and there was no impact to patient health or safety.

Event Description

It was reported that the bd facs¿ lyse wash assistant carried over contamination between samples.There was no report of 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 patient samples involved? yes.Is a confirmatory test always performed? yes.Was it obvious that the results could not be trusted? yes.Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.

• 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: 12835812
• MDR Text Key: 280954716
• Report Number: 2916837-2021-00444
• 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: 01/10/2022

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: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• 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