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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE Back to Search Results
Model Number 337146
Device Problem Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2022
Event Type  malfunction  
Event Description
It was reported that while using the bd facs¿ lyse wash assistant that there was erroneous results.The following information was provided by the initial reporter: whenever take tubes out there is not the correct number of cells left in the tube, something wrong with washing procedure.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
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 a complaint regarding incorrect number of cells left in the tube on 21sep2022.This poses the risk of producing erroneous results that might impact patient diagnosis and treatment.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 21sep2021 to 21sep2022.¿ device history record (dhr) review: dhr part #337146, serial # k33714600393, file #337146-337146-k33714600393-100073115-13, was reviewed.The instrument met all the manufacturing specifications prior to release.¿ complaint history review : there are 3 complaints related to the issue of erroneous diagnostic results; date range from 21sep2021 to 21sep2022.¿ returned sample analysis: the returned sample was received.The root cause of the defect could not be determined.However, upon examination by the repair center, it was noted that the body was damaged.Based on the cosmetic defect, the part is to be scrapped.The pictures are attached to tw.¿ service history review: review of related work order #: 02640018, case # 01804106 install date: 07jun2013 defective part number: 64844907 - face seal/ball seal/4th stage assembly work order notes: o subject / reported: 337146 - bd facs lyse wash assistant - not the correct number of cells left in the tube o problem description: whenever take tubes out there is not the correct number of cells left in the tube, something wrong with washing procedure.O work performed: ac 27.Sept.2022.The issue has been identified as the 4th stage block of the cell wash assembly, which was defective.This has been replaced successfully.- cleaning of the instrument performed.- power supply voltages checked.- compressor pressure checked.- leaktest performed on the pneumatic system.- valve functions checked.- vacuum calibration performed.- vacuum leakage test performed.- flushing of cell wash probe checked.- dispense function for lyse and fix solutions checked.- carousell positions checked.- function of tank sensors checked.- system attributes checked.Final inspection: - reliability test (with food-color) performed.The instrument performs to the instruments specifications and is ready for use without restrictions.O cause: ac 27.Sept.2022.Defective 4th stage of the cell wash assembly.O solution: ac 27.Sept.2022.Replaced 4th stage of the cell wash assembly.O parts replaced : 64844907 - face seal/ball seal/4th stage assembly ¿ risk analysis: risk management file part # 10000597659, rev.03 /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 o id: 3.1.9 o hazard: incomplete/ insufficient washing of sample o cause: mechanical error o harmful effects: improperly prepared samples that leads to inaccurate results o residual probability: 1 o residual severity: 3 o residual risk index: 3 ¿ potential causes: based on the investigation results the potential cause for the incorrect number of cells left in the tube was a defective 4th stage block of the cell wash assembly.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the potential cause for the incorrect number of cells left in the tube was a defective 4th stage block of the cell wash assembly.The customer reported a complaint regarding incorrect number of cells remaining the tube.The field service representative (fsr) confirmed the issue to be a defective 4th stage block of the cell wash assembly.The fsr proceeded to replace it.Further works performed included cleaning of the instrument, and a series of checks including power supply voltages, compressor pressure, leak test, carousel positions, function of tank sensors valve functions, flushing of the cell wash probe, dispense function for lyse and fix solutions and performing vacuum calibration and vacuum leakage test.A final inspection with food color was performed.After the works performed, the instrument was testing and was functioning as expected.No patient was treated nor harmed from incorrect results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant system instructions for use, #23-11113-00 rev.1/vers.A, page 101.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation results, the complaint was confirmed and the potential cause for the incorrect number of cells left in the tube was a defective 4th stage block of the cell wash assembly.The customer reported a complaint regarding incorrect number of cells remaining the tube.The field service representative (fsr) confirmed the issue to be a defective 4th stage block of the cell wash assembly.The fsr proceeded to replace it and performed a series of checks.After the works performed, the instrument was testing and was functioning as expected.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.¿ supporting document: n/a h3 other text : see h.10.
 
Event Description
It was reported that while using the bd facs¿ lyse wash assistant that there was erroneous results.The following information was provided by the initial reporter: whenever take tubes out there is not the correct number of cells left in the tube, something wrong with washing procedure.
 
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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 Key15718249
MDR Text Key307034888
Report Number2916837-2022-00329
Device Sequence Number1
Product Code JQW
UDI-Device Identifier00382903371464
UDI-Public00382903371464
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/20/2023
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 Model Number337146
Device Catalogue Number337146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2022
Initial Date FDA Received11/02/2022
Supplement Dates Manufacturer Received02/20/2023
Supplement Dates FDA Received03/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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