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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

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 while testing patient samples on bd facs¿ lyse wash assistant carryover occurred.There was no patient impact.The following information was provided by the initial reporter: carry over with instrument 1.Are there erroneous results on patient samples from 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? if yes answer 5 & 6 no.

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 carryover issue with the facs lyse wash assistant 337146.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 01oct2020 to 01oct2021.Complaint trend: there are 9 complaints related to the issue of carryover.Date range from 01oct2020 to 01oct2021.Manufacturing device history record (dhr) review: dhr part #337146 serial # k33714600121, file # 337146-k33714600121-900284892-11, 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 customer observing carryover could not be identified.The fse (field service engineer), could not replicate the issue after performing tests.Although, the fse did not observe any carryover, another unrelated problem was found with the reagent door.The door intermittently powered on and was replaced after checking that the cables were are all ok.The door was not requested for evaluation as its not returnable and was discarded.After the tests and repair the instrument was performing as expected.Although the initial complaint was carryover, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision.To help prevent carryover, 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, page 111.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2011.Defective part number: n/a.Work order notes: subject / reported: customer is having carry over with her instrument problem description: customer is having carry over with her instrument work performed: arrived onsite and tested with beads.Did not observe any carryover.Leaving open to monitor.**additional problem found: intermittently, reagent door is not powering on.Found that power is making it to the reagent door and leds are illuminated in the reagent door, but the screen never comes on.Rebooting will make it work, but the next day it will do the same thing.Checked power and red cable, all ok.Replaced reagent door and verified proper operation.Cause: unknown.Suspect connection in the reagent door causing intermittent power on issue.Solution: replacing reagent door resolved the issue.Instrument is functioning properly and has been returned to customer for use.Returned sample evaluation: a return sample was not requested because the replaced part, the instrument¿s reagent door, is not returnable and was discarded.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 id 2.1.1 for carryover and id 3.1.5 for loss of sample were identified and the safety risk is to be within the acceptable level.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; id: 3.1.5 ; hazard: loss of sample; cause: 1.Bad connector.2.Overheated components.3.Insufficient electrical grounding; harmful effects: delayed results; risk control: replaced fci connector with improved molex connector.Added cooling fan and vent holes to the reagent door assembly which resulted in 20 degree reduction to door internal temperature.Added ground cable between reagent door and main chassis to complete chassis ground connection to door.Implementation verification: reliability testing in sv lab; protocol gppd0010-03 rev a effectiveness systems level reliability test protocol and report probability: 1; severity: 3; risk index: 3; residual risk evaluation: a; new hazards: none.Root cause: based on the investigation results the root cause of the carryover issue could not be determined.Conclusion: based on the investigation results, the root cause of the customer experiencing carryover on the lwa instrument, could not be identified.The fse could not replicate the reported issue but resolved a separate issue of a faulty door by replacing it.No erroneous results were found and no samples were affected by this door.No one was harmed or injured, and no medical diagnosis was performed.The safety risk of this hazard has been identified to be within the acceptable level.

Event Description

It was reported that while testing patient samples on bd facs¿ lyse wash assistant carryover occurred.There was no patient impact.The following information was provided by the initial reporter: carry over with instrument 1.Are there erroneous results on patient samples from 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? if yes answer 5 & 6 no.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12721348
• MDR Text Key: 282356839
• Report Number: 2916837-2021-00423
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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: 10/01/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/25/2022
• 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