MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LWA; SEE H.10

Catalog Number 337408

Device Problem Contamination (1120)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Patient 3 of 3.Common device name: station, pipetting diluting clinical use.Initial reporter addr 1: (b)(6).Medical device serial: unknown as it could have come from 1 of 2 instruments with the serial numbers (b)(4) and (b)(4).

Event Description

It was reported that while using bd facs¿ lwa carryover between patient samples had occurred.The following information was provided by the initial reporter: patient 3 of 3.We removed the serial number from the complaint due to the customer not knowing which serial number the carryover happened on.It was reported by the customer that there is carryover on patient samples.1st patient affected ¿ was diagnosed with acute leukemia, admitted to hospital overnight, had bm tested.Bm test was negative.2nd patient affected ¿ results went to physician but were not relayed to patient, she thinks it was re-tested as neg.She thinks this was about the time they were investigating the first carryover, so were getting cautious.3rd patient affected ¿ lab pathologist caught it before being released.Happens with samples with high wbc or high blast concentrations.They were not diluting high concentration samples originally, they started diluting samples over 100k/ul, now diluting samples over 50k/ul.They also run a water tube between samples to reduce chance of carryover.Customer workaround for issue is to run one or more tubes of di water as a patient sample between actual patient samples to prevent carryover.Any sample that has a known white blood cell count about 50,000 (units unknown), customer is using the work around described above to prevent carryover.

Manufacturer Narrative

H.6: scope of issue: the scope of issue is only limited to lwa including external tank option, part # 337408.This complaint was reported by nebraska medical center.In this case, the serial number of the impacted instrument could not be determined, but the scope of the issue is limited to 3 lwa instruments in the lab with serial numbers: (b)(6), (b)(4).Problem statement: customer reported complaint regarding carryover on 02mar2023.This poses the risk of producing delayed or erroneous results that might impact patient diagnosis and treatment.All the instruments in scope were repaired and were found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part # 337408.Date range from 09mar2022 to 09mar2023.Device history record (dhr) review: dhr part # 337408 for above mentioned serial numbers were reviewed.Dhr file #: (b)(6), date of manufacturing : 22jul2019 (b)(6), date of manufacturing : 24mar2020 (b)(6), date of manufacturing : 20jun2019 all the instruments met all the manufacturing specifications prior to release.Complaint history review: there are 6 complaints for part # 337408 related to as reported code 1: contamination - carry over; (b)(4).Date range from 09mar2022 to 09mar2023.Returned sample analysis: a return sample evaluation was not requested because the parts replaced were not returnable and were discarded.Service history review: (b)(6).Review of related case # (b)(4).Install date: (b)(6) 2020.(b)(6).Review of related case # (b)(4).Install date: (b)(6) 2019.(b)(6).Review of related case # (b)(4).Install date: (b)(6) 2019.Summary: all three instruments had similar issues related to clogged restrictors (pn 342619).(b)(6) instrument also had low vacuum in fluidics and hence the valve stack was replaced.The restrictors were replaced in all three cases, and it was confirmed that the instruments were performing as intended after the replacements.Labeling / packaging review: n/a.Risk analysis: risk management file part # 10000597659, rev.03/vers.C, ra bd facs lyse wash assistant was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? ¿yes ¿no.Id: 3.1.1.Hazard: carryover.Cause: dirty spindle.Harmful effects: inaccurate results.Residual probability: 1.Residual severity: 3.Residual risk index: 3.Potential causes: based on the investigation results, the potential cause of the carryover could not be determined.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, service activity review, and additional carryover protocol test, the potential cause of the carryover could not be determined.The customer reported a complaint regarding carryover.Although carryover was found, erroneous results were not reported to the physician.No patients were treated or harmed using the results.In this case, the serial number of impacted instrument could not be determined.The field service engineer visited the lab and performed work on 3 lwas (sns above).All three instruments had similar issues related to clogged restrictors (pn 342619).The restrictors were replaced in all the cases.(b)(6) instrument also had low vacuum in fluidics and hence the valve stack was replaced.All the instruments were tested, and it was verified that they were functioning according to specifications.In addition to the fse visit, a carryover protocol test was performed on all three instruments on 14mar2023 per sb lwa-20-61_rev01.The instruments passed the test and did not exhibit carryover.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant instructions for use, #23-11113 rev.02/vers.A, starting page 107.Conclusion: based on the investigation results, the customer reported a complaint regarding carryover but a specific cause for the customer¿s complaint could not be confirmed.The customer reported a complaint regarding carryover.In this case, the serial number of the impacted instrument could not be determined.In the field service visits after the occurrences of carryover, the fse identified clogged restrictors on all instruments within scope and replaced them.However, since the cause of carryover could not be attributed to instrument failure and there was no impact to customer and patient health or safety, a capa/sa/scar is not required.In addition, a carryover protocol test that was performed on the instruments revealed no evidence of carryover outside of accepted levels.All the instruments were repaired and were found to be performing per specification.

Event Description

It was reported that while using bd facs¿ lwa carryover between patient samples had occurred.The following information was provided by the initial reporter: patient 3 of 3.We removed the the serial number from the complaint due to the customer not knowing which serial number the carryover happened on.It was reported by the customer that there is carryover on patient samples.1st patient affected ¿ was diagnosed with acute leukemia, admitted to hospital overnight, had bm tested.Bm test was negative.2nd patient affected ¿ results went to physician but were not relayed to patient, she thinks it was re-tested as neg.She thinks this was about the time they were investigating the first carryover, so were getting cautious.3rd patient affected ¿ lab pathologist caught it before being released.Happens with samples with high wbc or high blast concentrations.They were not diluting high concentration samples originally, they started diluting samples over 100k/ul, now diluting samples over 50k/ul.They also run a water tube between samples to reduce chance of carryover.Customer workaround for issue is to run one or more tubes of di water as a patient sample between actual patient samples to prevent carryover.Any sample that has a known white blood cell count about 50,000 (units unknown), customer is using the work around described above to prevent carryover.

• Brand Name: BD FACS¿ LWA
• Type of Device: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16542241
• MDR Text Key: 311584378
• Report Number: 2916837-2023-00073
• Device Sequence Number: 1
• Product Code: JQW
• 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: 08/01/2023

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 Catalogue Number: 337408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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