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 10/06/2020

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.Fda device problem code(s): (b)(4).Fda patient problem code(s): (b)(4).

Event Description

It was reported that during use with bd facs¿ lyse wash assistant carryover of samples occurred.There was no reported patient impact.The carryover between samples was observed by the customer when using the equipment.An internal protocol was developed by the advisory team to assess the problem and the carryover between samples was confirmed.The global team has developed an official protocol for evaluating the carryover and a meeting will be scheduled with the client to inform the recommendations of this protocol and verify the feasibility of not applying.Currently, the client has the equipment in routine using a tube with saline solution between samples to avoid carryover.

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 0 qns (quality notifications) related to the reported issue.Date range from 30oct2019 to date 30oct2020.Complaint trend: there are 3 complaints related to sample carryover; date range from 30oct2019 to date 30oct2020.Manufacturing device history record (dhr) review: dhr part #337146 serial # (b)(6), file # 337146-337146-k33714600526-100220337-14, 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 observed with their instrument and prompted the development of a global protocol for carryover.Carryover with this instrument was observed by this customer starting 05oct2020 and persisted until the release of the new lwa carryover protocol (23-23520-00) in november, 2020.This protocol describes the proper method in preparing the samples and running analyses on these samples.Using this new protocol, a field specialist determined that the customer¿s instrument did not show signs of carryover, as seen in task 2607411 ¿ wfi-investigation.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 # (b)(4).Install date: 26aug2016.Defective part number: n/a.Work order notes: subject / reported: carryover between samples.Problem description: the carryover between samples was observed by the customer when using the equipment.An internal protocol was developed by the advisory team to assess the problem and the carryover between samples was confirmed.The global team has developed an official protocol for evaluating the carryover and a meeting will be scheduled with the client to inform the recommendations of this protocol and verify the feasibility of not applying.Currently, the client has the equipment in routine using a tube with saline solution between samples to avoid carryover.Work performed: n/a.Cause: n/a.Solution: the carryover protocol was performed and the results were satisfactory.No carryover was observed.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: 2.1.1.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.The root cause of the misinterpreted carryover issue was due to an outdated sample preparation protocol that was updated soon after the incident.Conclusion: based on the investigation, carryover was not observed and thus a root cause could not be determined.The customer submitted a complaint regarding carryover observed between samples and an internal protocol was developed for lwa carryover that outlines proper procedures for sample preparation and analysis.After the new protocol¿s creation, it was verified by a field specialist there was no carryover observed on this instrument.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.H3 other text : see h10.

Event Description

It was reported that during use with bd facs¿ lyse wash assistant carryover of samples occurred.There was no reported patient impact.The carryover between samples was observed by the customer when using the equipment.An internal protocol was developed by the advisory team to assess the problem and the carryover between samples was confirmed.The global team has developed an official protocol for evaluating the carryover and a meeting will be scheduled with the client to inform the recommendations of this protocol and verify the feasibility of not applying.Currently, the client has the equipment in routine using a tube with saline solution between samples to avoid carryover.

• 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: 10770830
• MDR Text Key: 214148050
• Report Number: 2916837-2020-00222
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• 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: 10/06/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1