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 of Device Ingredient or Reagent (2901)

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

Event Date 02/25/2022

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 caused carryover between tubes during sample preparation.There was no report of adverse patient impact.The following information was provided by the initial reporter: "customer reports that there is quite some carry-over from one tube to another during sample preparation.The issue did not affect significantly the results so far.Customer is still investigating the effect of the issue on patient's results." were samples contaminated? --yes.Are there erroneous results on patient samples for diagnostic test? --yes.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 caused carryover between tubes during sample preparation.There was no report of adverse patient impact.The following information was provided by the initial reporter: "customer reports that there is quite some carry-over from one tube to another during sample preparation.The issue did not affect significantly the results so far.Customer is still investigating the effect of the issue on patient's results." 1.Were samples contaminated? --yes.1.Are there erroneous results on patient samples for diagnostic test? --yes.2.Was there any delay of treatment due to the issue? --no.3.If patient samples were redrawn, was there any change or delay of treatment? --no.4.Was there any physical harm/injury to the patient due to the issue? --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 the issue of carryover between sample tests.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 08mar2021 to 08mar2022.¿ complaint trend: there are 9 complaints related to the issue of carryover between sample tests; pr# (b)(4).Date range from 08mar2021 to 08mar2022.¿ manufacturing device history record (dhr) review: dhr part #337146 serial # (b)(6), file # 337146-337146-k33714600572-100575954-15, 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 was due to incorrectly configured cell wash block tubing.The customer had initially reported that they observed carryover during sample preparation.The fse (field service engineer) discussed the issue with the customer and the customer noted that the issue occurred before a recent preventative maintenance with ~1300 events and after the preventative maintenance at ~50 events.The fse ran the cell wash test with the top cover removed and found that the spindle stream was abnormal.Upon further visual inspection, the cell wash block assembly¿s tubing was incorrectly configured.After correctly configuring the tubing, the top cover was refitted and the cell wash test was run again and passed.The customer then ran 3 samples to confirm that the carryover had been resolved and the instrument was determined to be functioning as expected.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.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02365810, case # (b)(4).Install date: 15apr2015.Defective part number: n/a.Work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - carry-over issue.O problem description: customer reports that there is quite some carry-over from one tube to another during sample preparation.The issue did not affect significantly the results so far.Customer is still investigating the effect of the issue on patient's results.O work performed: dj 10mar2022 - discussed fault with customer - issue occurred right before recent preventative maintenance intervention - carry over at end of day towards end of run ~1300 events.After preventative maintenance significantly improved but still ~50 events.Ran cell wash test with top cover off - stream from spindle abnormal - visual inspection showed wash block assembly tubing incorrectly configured - wash solution input into vent block and vent line input into wash block.Correctly configured tubing of cell wash block - ran cell wash test again - wash stream from spindle now normal.Refitted cover and ran cell wash test again - all okay.Customer prepared 3 samples - each sample tube followed by empty tubes for pbs collection during wash step to check for carry over - ran samples on canto - no carry over seen - issue resolved.Completed service report and emailed to customer.Repair intervention completed successfully.O cause: dj 10mar2022 - incorrectly configured tubing into wash block assembly.O solution: dj 10mar2022 - correctly configured wash block tubing.¿ returned sample evaluation: a return sample was not requested because there were no parts replaced.¿ risk analysis: risk management file part # 337146ra, rev.01/vers.B, 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: 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.O id: 3.1.4.O hazard: 1.Unprepped sample.2.No answer.3.Loss of sample.O cause: 1.Non recommended tube.2.Sensor window dirty.O harmful effects: 1.Delayed or no results.2.Increased cost of test due to the need to reprep and rerun.3.Blood exposure is higher risk without fixative.O risk control: 1.Screen displays tube 2.Customer inspects processed rack 3.Users guide specifications for proper tube.O implementation verification: ec01147e504878.O effectiveness verification: lwa-09-02p and -02f stress and hazards testing.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 was due to an incorrectly configured cell wash block tubing.¿ conclusion: based on the investigation results the root cause of the carryover was due to an incorrectly configured cell wash block tubing.The fse started by performing a preventative maintenance on the instrument but the issue persisted.The stream from the spindle was found to be abnormal and a visual inspection of the cell wash block assembly confirmed an incorrect configuration of the tubing.After refitting the tubing and cover, the instrument was tested and confirmed to be functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13950729
• MDR Text Key: 289507767
• Report Number: 2916837-2022-00075
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/28/2022

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: 03/10/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1