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 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd facs¿ lyse wash assistant carryover contamination occurring between tubes.The following information was provided by the initial reporter: customer reports that there appears to be sample carryover contamination between tubes.

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: the customer reported a complaint regarding carryover contamination issues that occurred on (b)(6) 2022.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 no users or patients were harmed due to this issue.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue for part # 337146.Date range from (b)(6) 2021 to date (b)(6) 2022.¿ 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.¿ complaint history review: there are 12 complaints related to the issue of carryover for part # 337146; date range from (b)(6) 2021 to date (b)(6) 2022.¿ returned sample analysis: a return sample was not requested for evaluation because the potential cause of the carryover was determined using the servicemax review.After the repair, the instrument was found to be functioning as expected.¿ service history review: review of related work order #: (b)(4); case #: (b)(4) install date: (b)(6) 2015 defective part number: 64845019 - assy valve stack blue repaired work order notes: o subject: sample cross contamination o description: customer reports that there appears to be sample carryover contamination between tubes o work performed: o (b)(6) 2022 verification of the problem: it is found that the rinsing of the cell wash assembly probe does not take place correctly due to fluid blockages in the dedicated line.The correct functionality of the rinse is restored.Subsequent tests with customer test samples show partial resolution.Spare parts are ordered.O (b)(6) 2022 replacement of the valve group #(b)(6), general check of good functioning according to bd specifications.We proceed together with the customer to verify with blood samples for the appropriate determination of the resolution of the problem.It is left on trial for 48 hours.O (b)(6) 2022 the customer confirms the resolution of the problem o cause: fluidic o solution comments: cell wash assembly probe rinsing functionality restored.Additional spare parts are ordered.O (b)(6) 2022 replacement of the valve group #(b)(6), general check of good functioning according to bd specifications.We proceed together with the customer to verify with blood samples for the appropriate determination of the resolution of the problem.It is left on trial for 48 hours.O (b)(6) 2022 the customer confirms the resolution of the problem ¿ labeling / packaging review: n/a ¿ 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 hazard id #:(b)(6) o hazard: carryover o cause: clogged orifice o harmful effects: inaccurate results o residual probability: 1 o residual severity: 3 o residual risk index: 3 ¿ potential causes: based on the investigation, the potential cause was determined to be the cell wash assembly probe not rinsing properly due to blockages.¿ 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 was determined to be the cell wash assembly probe not rinsing properly due to blockages.In response to the customer¿s complaint regarding carryover between tubes, an fse (field service engineer) went onsite, confirmed the issue, and found the cell wash assembly probe was not rinsing properly due to blockages in the dedicated fluid lines.The fse replaced the valve stack assembly (part # 64845019 - assy valve stack blue repaired), which resolved the issue.After this repair, the instrument was tested and found to be functioning as per bd specifications with no further carryover.Although carryover issues pose the risk of erroneous results, the customer confirmed that there were no erroneous results on patient samples.Thus, no patients were harmed or treated due to this issue.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.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation, the complaint was confirmed and the potential cause of the carryover between tubes was determined to be the cell wash assembly probe not rinsing properly due to blockages.The fse replaced the valve stack assembly (part # 64845019), which resolved the issue.After this repair, the instrument was found to be working as per bd specifications.No erroneous results were obtained from patient samples in diagnostic tests, and no patients were harmed due to the carryover issue.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.¿ supporting document: n/a h3 other text : see h.10.

Event Description

It was reported that bd facs¿ lyse wash assistant carryover contamination occurring between tubes.The following information was provided by the initial reporter.Customer reports that there appears to be sample carryover contamination between tubes.

• 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 Key: 15986989
• MDR Text Key: 308487712
• Report Number: 2916837-2022-00365
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/08/2023

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: 12/02/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1