MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS CALIBUR¿

Catalog Number 343023

Device Problem Contamination (1120)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone #: (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 running bd facs calibur¿ contamination in sample line was discovered.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: measuring cell contaminated.

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is only limited to facscalibur 4 clr with sort sensor unit, part # 343023, serial # (b)(6).¿ problem statement: customer reported complaint regarding their instrument producing erroneous results.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2020 to (b)(6) 2021.¿ complaint trend: there are (b)(4) complaints related to the issue of erroneous results.Date range from (b)(6) 2020 to (b)(6) 2021.¿ manufacturing device history record (dhr) review: dhr part # 343023 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the carryover between sample tests was due to a worn flowcell assembly.The customer initially reported that the instrument was exhibiting carryover, and an estimate was provided that detailed the travel, labor, and cost of the flowcell (pn 02-61849-01s) needed for the repair.The customer then informed the tsr (technical service representative) that they were not interested in repairing the instrument due to the instrument¿s age.No parts were requested for evaluation as there were no parts replaced.Although the erroneous results were of patient samples, these erroneous results did not delay or otherwise affect the treatment of any patient.The safety risk is limited, s2, and there was no impact to patient health or safety.¿ service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2001.Defective part number: n/a.Work order notes: o subject / reported: calibur measuring cell.O problem description: measuring cell contaminated.1 x 02-61849-01s.4h az.1 h rz.Small flat rate.O work performed: n/a.O cause: n/a.O solution: the customer does not want to repair the device due to its age and possible new purchases.¿ returned sample evaluation: a return sample was not requested because there were no parts replaced.¿ risk analysis: risk management file part # 342973ra, rev.04/vers.D, bd facscalibur product family risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no.O id: 3.1.4.O hazard: operational hazard ¿ fl3 separation qc failure.O cause: fl3 filter¿s optical characteristic is not optimal.O harmful effects: cannot proceed with clinical results after qc failure.O risk control: new fl3 filer to optimize optical characteristics.O implementation verification: verification protocol and report vp12256.O effectiveness verification: 500000189287.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient yes no.¿ root cause: based on the investigation results the root cause of the carryover between samples was due to a worn flowcell.¿ conclusion: based on the investigation results the root cause of the carryover between samples was due to a worn flowcell.An estimate for the flowcell, travel, and labor costs needed for an fse to repair the instrument was provided to the customer.After receiving this information the customer informed the tsr that they were not interested in repairing this instrument at the moment.No one was harmed or injured, and there was no impact to the treatment of any patients due to the erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.

Event Description

It was reported that while running bd facs calibur¿ contamination in sample line was discovered.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: measuring cell contaminated.

• Brand Name: BD FACS CALIBUR¿
• Type of Device: NA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12442673
• MDR Text Key: 274339453
• Report Number: 2916837-2021-00368
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/06/2021

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: 343023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1