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

Model Number 337146

Device Problem Contamination (1120)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: station, pipetting diluting clinical use.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 using bd facs¿ lyse wash assistant that there was carryover involving patient samples.The following information was provided by the initial reporter: customer reports that the instrument is showing higher rates of carryover between one tube and the other.

Manufacturer Narrative

H.6 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 complaint regarding carryover issues that occurred on (b)(6) 2023.Carryover 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 19jan2022 to 19jan2023.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.Complaint history review: there are 15 complaints related to the issue of carryover; date range from 19jan2022 to 19jan2023.Returned sample analysis: complaint sample was not requested for evaluation because the potential cause of the complaint was determined to be a defective cell wash assembly using servicemax review.The part was replaced, and the instrument found to be functioning as expected.Service history review: review of related work order #: 02808306, 02807365 case # 01909404.Install date: 15-apr-2015.Defective part number: 64861719 - assy cell wash mechanism blue repaired work order: 02808306 notes: subject reported: 337146: bd facs lyse wash assistant: - carryover issue problem description: customer reports that the instrument is showing higher rates of carryover between one tube and the other.Work performed: 25 -jan- 23 rk : cell wash probe assembly stripped and cleaned then re-assembled.System tested with wash only protocol and 8 peak beads in alternate tubes and pbs in between.Pbs tubes run on facscanto ii no carryover detected.Customer will monitor.If symptoms recur i recommend ordering: 64861717 cell wash assembly.Wo put to fa.Dj 07mar2023, replaced cell wash assembly.Completed work on pm wo-02780553.Performance verification passed.Customer ran patient sample tube followed by pbs tube for multiple samples for testing on canto ii verified no more carry over issue resolved.Repair intervention completed successfully.Cause: dj 07mar2023 cell wash assembly.Solution: dj 07mar2023: replaced cell wash assembly.Parts replaced: 64861719 assy cell wash mechanism blue repaired.Case comments: details on the quality questions for patient safety: yes this was a patient sample the incorrect result was obtained.We did further testing and verified that it was incorrect therefore it was not reported and the correct result was eventually authorised.This delayed the patient result due to the further testing we had to undergo.This would have unlikely impacted the patient because it forms part of an integrated report from different departments.- this problem is a high risk quality issue that is impacting our service.We have had to introduce extra wash cycles and we are using more scientist time to check through results for carryover.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.Hazard 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, the potential cause was determined to be a faulty 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 service activity review, the potential cause was determined to be faulty cell wash assembly.The customer reported the issue of carryover observed in patient samples.In response, fsr(field service representative) visited the site and investigated the issue.The fsr cleaned the cell wash assembly, but carryover persisted.The fsr then replaced the cell wash assembly after which the instrument was tested by the customer and functioning as expected.Although there was delay in patient result, no erroneous results were reported to the clinicians.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.Troubleshooting procedures can be found in the ifu starting on page 145.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation, the complaint was confirmed.The potential cause was determined to be faulty cell wash assembly.The fsr replaced the part and after subsequent testing by the customer, the instrument was functioning as expected.No one was harmed or injured, and no patients were harmed from any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.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.

Event Description

It was reported that while using bd facs¿ lyse wash assistant that there was carryover involving patient samples.The following information was provided by the initial reporter: customer reports that the instrument is showing higher rates of carryover between one tube and the other.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16247715
• MDR Text Key: 309025202
• Report Number: 2916837-2023-00012
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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 Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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