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 02/23/2023

Event Type  malfunction  

Event Description

It as reported that while using bd facs¿ lwa carryover between patient samples had occurred.The following information was provided by the initial reporter: carryover of some sort between tubes and blood may have gotten into other sample tubes pr (b)(4).It was reported by the customer that the instrument is leaking.1.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): = liquid.2.Was the leak contained within the instrument? (if not contained, go to question #3.If contained, no further questions required.): = not contained.3.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): = no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): = unknown.5.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): = unknown.6.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further question required.): = yes.1.Were samples contaminated? (if no, no further questions required.If yes or unknown, go to patient samples checklist): = unknown.1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): = unknown.2.Was there any delay of treatment due to the issue? (go to question #3): = no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): = no.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): = no.

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 as reported that while using bd facs¿ lwa carryover between patient samples had occurred.The following information was provided by the initial reporter: carryover of some sort between tubes and blood may have gotten into other sample tubes pr (b)(4) it was reported by the customer that the instrument is leaking.1.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): = liquid.2.Was the leak contained within the instrument? (if not contained, go to question #3.If contained, no further questions required.): = not contained.3.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): = no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): = unknown.5.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): = unknown.6.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further question required.): = yes.1.Were samples contaminated? (if no, no further questions required.If yes or unknown, go to patient samples checklist): = unknown.1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): = unknown.2.Was there any delay of treatment due to the issue? (go to question #3): = no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): = no.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): = no.

Manufacturer Narrative

: 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.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.Date range from 28feb2022 to 28feb2023.Device history record (dhr) review: dhr part # 337408 serial # (b)(4), file # 337146-337146-r337146000962-106695823-20, was reviewed.The instrument met all the manufacturing specifications prior to release.Manufacturing date : 24mar2020 complaint history review: there are 3 complaints related to as reported code 1: contamination - carry over; pr (b)(4), (b)(4) and this one, pr (b)(4).Date range from 28feb2022 to 28feb2023.Returned sample analysis: a return sample evaluation was not requested because the part replaced is not returnable.Service history review: review of related work order #: (b)(4) case # (b)(4).Install date: 02apr2020.Defective part number: n/a work order notes: subject / reported: instrument is leaking issue problem description: instrument is leaking issue work performed: arrived on site to complete a repair on serial number (b)(4) located at nebraska medical center in omaha, ne.I completed the repair as per lwa service manual doc.Number 335322.Cause: clogged fitting / interconnect board solution: the instrument is testing without errors and i have returned the instrument to the lab for normal use, unit is operational.Problem 1 = instrument is leaking.Problem 2 = door solenoid is making rattling sound when unit is turned on.Problem 1 = the cell wash assembly¿s well was overflowing because the drain fitting was clogged.The fitting was unclogged and cleaned.After this the well drained properly and there were no more leaks.Problem 2 = replaced the interconnect board with and upgraded version which takes care of the rattling sound problem of the door solenoid.Ran wash only, fix dispense and lyse dispense cycles for several tubes without issues.Unit was left working properly.Parts replaced: 34474217 - pcb assembly interconnect svc 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: 3.Id: 3.1.4 hazard: 1.Un-prepped sample.2.No answer.3.Loss of sample.4.Safety biohazard.Cause: defective valves.Harmful effects: inaccurate results.Residual probability: 1.Residual severity: 3.Residual risk: 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, and service activity review, the potential cause of the carryover could not be determined.The customer reported a complaint regarding an instrument leak (addressed in pr# (b)(4)) and carryover (this one, pr # (b)(4)).The field service representative (fsr) confirmed that the drain fitting was clogged.The fsr noted that the cell wash assembly¿s well was overflowing because the drain fitting was clogged.In an attempt to resolve the issue, the fsr cleaned and unclogged the fitting.After the repair activity, the well drained properly.The instrument was tested and was performing as expected.Later, in (b)(4), the fsr replaced a semi clogged restrictor, did a check for carryover, and verified the instrument¿s performance.After the works performed, the instrument was functioning as intended.Although carryover was found, no erroneous results were reported to the clinician.No patients were treated or harmed using the results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant user¿s guide, #23-11113-00 rev.1/vers.A, page 101.Conclusion: based on the investigation results, complaint was confirmed and the potential cause could not be determined.The customer reported a complaint regarding carryover.The fsr confirmed that the drain fitting of the cell wash assembly¿s well was clogged.They proceeded to clean and unclog it.In (b)(4), the fsr replaced a semi clogged restrictor, did a check for carryover, and verified the instrument¿s performance.After the works performed, the instrument was functioning as intended.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.

• 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: 16497653
• MDR Text Key: 311587185
• Report Number: 2916837-2023-00064
• 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: 08/08/2023

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 Catalogue Number: 337408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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