MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LWA; STATION, PIPETTING DILUTING CLINICAL USE

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

Initial reported address 1 - (b)(6).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¿ lwa carryover between patient samples had occurred.The following information was provided by the initial reporter: it was reported by the customer that there is carryover on patient samples.Were samples contaminated? yes.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.Provide details- how and to what extent? there was unnecessary bone marrow draw from the patient due to false positive reading from lwa.

Manufacturer Narrative

Patient 2 of 3.The following fields have been updated with corrected and/or additional information.D.9 - removal of serial number as it could be one of two instruments: sn# (b)(6), sn# (b)(6).

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: it was reported by the customer that there is carryover on patient samples.We removed the serial number from the complaint due to the customer not knowing which serial number the carryover happened on.Were samples contaminated? yes.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.Provide details- how and to what extent? there was unnecessary bone marrow draw from the patient due to false positive reading from lwa.

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:  the initial mdr stated that the issue caused an unnecessary bone marrow draw from the patient due to false positive reading from lwa.The customer has now confirmed that this reported event did not cause an unnecessary bone marrow draw from the patient.Were samples contaminated? yes.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue?: no.If patient samples were redrawn, was there any change or delay of treatment?: no.Was there any physical harm/injury to the patient due to the issue?: no.Provide details- how and to what extent?: there was unnecessary bone marrow draw from the patient due to false positive reading from lwa.

Manufacturer Narrative

H.6: ¿ scope of issue: the scope of issue is only limited to lwa including external tank option, part # 337408 and serial # (b)(6).¿ problem statement: customer reported complaint regarding carryover on (b)(6) 2023.This poses the risk of producing delayed or erroneous results that might impact patient diagnosis and treatment.Erroneous results were reported to the clinician.However, this was not relayed to the patient.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 zero qns (quality notifications) related to the reported issue for part # 337408.Date range from (b)(6) 2022 to (b)(6) 2023.¿ device history record (dhr) review: dhr part # 337408 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Instrument date of manufacture: 22jul2019 ¿ complaint history review: there are 5 complaints for part # 337408 related to as reported code 1: contamination - carry over; (b)(4).Date range from (b)(6) 2022 to (b)(6) 2023.¿ returned sample analysis: a return sample evaluation was not requested because the part replaced is not returnable and was discarded.¿ service history review: review of related work order #: (b)(4), case # (b)(4) install date: (b)(6) 2019 defective part number: 342619 work order notes: (b)(4) o subject / reported: carryover issue o problem description: carryover issue o work performed: ¿ arrived on site to complete a repair on serial number (b)(6) located at nebraska medical center in omaha, ne.I completed the repair as per lwa service manual doc.Number (b)(4).O cause: clogged restrictor o solution: ¿ the instrument is testing without errors and i have returned the instrument to the lab for normal use, unit is operational.¿ verified unit¿s performance due to carryover issues.Test results are within bd specs.It was found that the restrictor in the spindle cleanse tubing was clogged.Only a few drops of spindle cleanse solution were being dispensed.A new restrictor was installed p/n 342619, non-stock item.After the restrictor replacement the spindle cleanse solution was dispensed freely to the spindle.Unit was left working properly.O parts replaced: 342619 ¿ 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 o id: 3.1.1 o hazard: carryover o cause: dirty spindle o harmful effects: inaccurate results o residual probability: 1 o residual severity: 3 o residual risk index: 3 ¿ potential causes: in the field service visit after the occurrence, the fse identified a clogged restrictor and replaced it.However, the potential cause cannot 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.The carryover resulted in erroneous results and was reported to the physician.Although carryover was found and erroneous results were reported to the physician, these were not relayed to the patient.No patients were treated or harmed using the results.In (b)(4), the field service engineer (fse) visited the site to inspect and repair the instrument.They found that the restrictor in the spindle cleanse tubing was clogged.They installed a new restrictor (pn 342619).The instrument was tested, and it was verified that it was functioning according to specifications.In addition to the fse visit, a carryover protocol test was performed on this instrument on (b)(6) 2023 per sb lwa-20-61_rev01.The instrument 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 the field service visit after the occurrence of carryover, the fse identified a clogged restrictor and replaced it.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 instrument revealed no evidence of carryover outside of accepted levels.The instrument was repaired and was 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:  the initial mdr stated that the issue caused an unnecessary bone marrow draw from the patient due to false positive reading from lwa.The customer has now confirmed that this reported event did not cause an unnecessary bone marrow draw from the patient.Were samples contaminated? yes.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.Provide details- how and to what extent? there was unnecessary bone marrow draw from the patient due to false positive reading from lwa.

• Brand Name: BD FACS¿ LWA
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16497655
• MDR Text Key: 310878931
• Report Number: 2916837-2023-00062
• 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,Followup,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: 03/07/2023
• Supplement Dates Manufacturer Received: 03/02/2023; 05/22/2023; 08/01/2023
• Supplement Dates FDA Received: 03/14/2023; 05/25/2023; 08/09/2023
• 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