MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

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 there were erroneous results.There was no report of patient impact.The following information was provided by the initial reporter: when you unplug the water container, nothing happens.It continues to operate without an alarm.Then, when connected the volume of water does not decrease.We have noticed that in tubes negative for cd3 for example, we have positive cd3 events.

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 a complaint regarding their instrument not detecting the water container and producing erroneous results.¿ manufacturing defect trend: there are (b)(4) qns (quality notifications) related to the reported issue.Date range from (b)(4) 2019 to date (b)(4) 2020.¿ complaint trend: there are (b)(4) complaints related to the issue of erroneous results; pr# (b)(4) , and this one, (b)(4).Date range from (b)(4) 2019 to date (b)(4) 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, the root cause of the instrument not detecting the water container and producing erroneous results was due to a worn liquid pump.Incorrect detection of the waste container can lead to the instrument believing the container is empty and skip cleaning between samples.This complaint was originally under another complaint where the customer submitted a complaint regarding the waste container detection and erroneous results, but was eventually closed due to being not mdr reportable.In this case, the complaint has been evaluated as mdr reportable as it poses a ¿clinically significant prolongation in diagnostic identification and therefore treatment.¿ the complaint details and work performed to repair this instrument can be found in servicemax under case (b)(4) and (b)(4).The customer had detailed that the instrument operated while disconnected from the water container without alarm, the water container would not decrease, and samples that were supposed to be negative in cd3 would have positive cd3 events suggesting carryover.The fse (field service engineer) responding to the complaint confirmed the issue and changed the instrument¿s liquid pump (pn 346340) as it was evaluated to be defective.No parts were requested for evaluation as the replaced part is not returnable and was discarded.After the repair, the fse tested the instrument with 5 tubes with no abnormalities, and confirmed that the instrument was functioning per bd specifications.Although this instrument was being used for clinical diagnoses, the customer confirmed that this incident did not delay or affect the treatment of a patient, and no patients were harmed in any way.The erroneous results collected during the incident were identified and not used for the treatment of a patient.The safety risk for this event 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) 2018.Defective part number: 346340 - pump liquid 1/8 barb.Work order notes: o subject: 337146 - bd facs lyse wash assistant - water can not detected.O description: when you unplug the water container, nothing happens.It continues to operate without an alarm.Then, when it is connected the volume of water does not decrease.It has been noticed that in tubes negative for cd3 for example, we have positive cd3 events.O work performed: pump change 346340.Test on 5 tubes no abnormality.The system is operational and conforms to bd specifications.O cause: 346340 pump defective.O solution: pump change 346340.¿ returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.¿ risk analysis: risk management file part # 337408ra, rev.01/vers.A, bd facs¿ lyse/wash assistant (lwa) system hazards analysis report was reviewed.No new hazards have been identified and the current mitigation is sufficient.The severity rating in this file is ¿6c¿ based on a previous scale rating.This rating is equivalent to ¿s3¿ in sop6078-02 rev.12/vers.J, whereby the unexpected result is obvious or indicated by additional (warning) information and does not pose a risk a significant risk of serious injury to the patient, hence the impact to the patient is negligible to none.The risk acceptability of this risk is moderate.Hazard(s) identified? yes, no.O 1.Performance problems.O hazard: loss of sample.O target & effect: 1-delayed or no diagnosis.2-increased cost of test due to need to reprep and rerun.O cause: n/a.O basic event: 1.6.1.1.2 empty supply tank.O risk controls: 1.Tank level detection.2.Visible fluid levels.3.Software v&v on tank level detection.O final risk: 6c.Mitigation(s) sufficient yes, no.¿ root cause: based on the investigation the root cause of the erroneous results was due to a worn liquid pump.¿ conclusion: based on the investigation the root cause of the erroneous results was due to a worn liquid pump.The fse confirmed the issue and switched the instruments liquid pump (pn 346340).After the repair, the instrument was tested with 5 tubes and was confirmed to be operating as expected.No one was harmed or injured, and no patients were harmed from any potential erroneous results.The safety risk for this event is moderate, s3, and there was no impact to patient health or safety.

Event Description

It was reported that while running patient samples on a bd facs¿ lyse wash assistant there were erroneous results.There was no report of patient impact.The following information was provided by the initial reporter: when you unplug the water container, nothing happens.It continues to operate without an alarm.Then, when connected the volume of water does not decrease.We have noticed that in tubes negative for cd3 for example, we have positive cd3 events.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11006488
• MDR Text Key: 221550231
• Report Number: 2916837-2020-00307
• 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: NA
• 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: 10/29/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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