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 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a bd facs¿ lyse wash assistant caused carryover.The following information was provided by the initial reporter: "customer complaint during my visit on (b)(6) 2020 that he has the impression that there is some carry over by using his lwa.Measurement of 4 replicates cd45/3/4/8/19 stained samples, detecting the different populations in 2nd tube after first full stained tube.Exceeding 0.005% (spec.) carry over by factor 3 (0,018%) in average, ranging from factor 2 - factor 4.".

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 complaint of 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 7 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, and risk analysis, the root cause of carryover could not be determined.There was not case nor work order created in servicemax.However, there was email correspondence in the entry description in trackwise that states that a technical service representative (tsr) helped resolve the issue.A new lwa carryover protocol (23-23520-00 rev.1/vers.A) was made available in (b)(6), 2020 to customers and users.This protocol describes the proper method in preparing the samples and running analyses on these samples.The email also confirmed that no patient samples were affected nor were there erroneous results used for patient treatment.No one was harmed or injured.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) 2020 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 the root cause could not be determined.Conclusion: based on the investigation a root cause could not be determined.With no open case, the tsr helped resolve the issue with no further complaint.A new carryover protocol was made available to customers guiding proper preparation and method to assist with carryover issues.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.

Event Description

It was reported that a bd facs¿ lyse wash assistant caused carryover.The following information was provided by the initial reporter: "customer complaint during my visit on 19th november that he has the impression that there is some carry over by using his lwa.Measurement of 4 replicates cd45/3/4/8/19 stained samples, detecting the different populations in 2nd tube after first full stained tube.Exceeding 0.005% (spec.) carry over by factor 3 (0,018%) in average, ranging from factor 2 - factor 4.".

• 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: 10994737
• MDR Text Key: 221275062
• Report Number: 2916837-2020-00302
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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: 11/23/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1