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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

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.(b)(4).

Event Description

It was reported that while running patient samples on a bd facs¿ lyse wash assistant carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: carryover issues - unrelated failure found on escalation are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.

Event Description

It was reported that while running patient samples on a bd facs¿ lyse wash assistant carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: carryover issues - unrelated failure found on escalation.Are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.

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 complaint on erroneous results due to carryover issues.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from (b)(6) 2019 to date (b)(6) 2020.Complaint trend: there are 6 complaints related to the issue of carryover.Date range from (b)(6) 2019 to date (b)(6) 2020.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, it was determined that there was no carryover observed within this instrument according to the new carryover protocol.The customer reported the issue of carryover during another case regarding tube engagement issues (case (b)(4)) and can be seen in escalation (b)(4).Carryover with this instrument was observed by this customer starting (b)(6) 2020 and persisted until the release of the new lwa carryover protocol (23-23520-00) in (b)(6) , 2020.This protocol describes the proper method in preparing the samples and running analyses on these samples.Using this new protocol, the customer stated that they no longer observed carryover and that there were no further issues on that instrument.The fse also confirmed that no patient samples were affected nor were there erroneous results per task 2158875 ¿ information request #3.The safety risk for carryover between samples is moderate, s3, and there was no impact to patient health or safety.Service max review: review of related work order #: n/a case # n/a.Install date: (b)(6) 2011.Defective part number: n/a.Work order notes: n/a.-this issue was found during case 01137160 and a separate case was not created for it.Returned sample evaluation: a return sample was not requested because there were no replaced parts.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.Id: (b)(4).Hazard: carryover.Cause: clogged orifice.Harmful effects: incorrect results, damaged instrument.Risk control: replace orifice at each pm interval.Implementation verification: reliability testing in sv lab; protocol: gppd0010-03 rev a.Effectiveness verification: system characterization summary report lwa carryover evaluation phase iii version 1.0 10/mar/2010.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient yes / no.Root cause: based on the investigation, carryover was not observed and thus a root cause could not be determined.Conclusion: based on the investigation, carryover was not observed and thus a root cause could not be determined.The customer reported the issue of carryover during a previous complaint, and was later advised to run their instrument under the new lwa carryover protocol.Using this protocol the customer no longer observed carryover and the fse confirmed that there were no erroneous results.After the evaluation on carryover, the instrument continued to run as expected.No one was harmed or injured, and no patients were harmed from any potential erroneous results.The safety risk for carryover between samples 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
• MDR Report Key: 11016000
• MDR Text Key: 247272529
• Report Number: 2916837-2020-00309
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1