MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H10

Model Number 647205

Device Problem Contamination (1120)

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

Event Date 02/19/2022

Event Type  malfunction  

Event Description

It was reported that while testing patient samples with bd facs¿ sample prep assistant iii carryover occurred.The results were not reported and there was no patient impact.The following information was provided by the initial reporter: it was reported that spa has too much carryover.Are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Medical device expiration date: unknown.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 testing patient samples with bd facs¿ sample prep assistant iii carryover occurred.The results were not reported and there was no patient impact.The following information was provided by the initial reporter: it was reported that spa has too much carryover.Are you using this product for clinical diagnostic test? y.Were erroneous results reported and used to treat a patient? n.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: spa has too much carryover.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 19feb2021 to date 19feb2022 (rolling 12 months).Complaint trend: there is 1 complaint related to the reported complaint.Date range (date of incident to 12 months back) from 19feb2021 to date 19feb2022 (rolling 12 months).Investigation result / analysis: per fse report: inspected instrument and found that there was air through all the lines and that the sheath tank was disconnected preventing proper flow.Reconnected sheath and primed system until air was removed.Ran 10 tubes without any issues.Although the unexpected results were from patient samples for clinical use, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision and were immediately noticed and retested.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order# (b)(4).Install date: 01apr2012.Defective part number: there were no defective parts.Work order notes: subject / reported: spa has too much carryover.Problem description: carryover.Cause: air in fluid lines and disconnected sheath tank.Work performed: reconnected sheath tank.Solution: reconnected sheath tank.Returned sample evaluation: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes or no.Hazard id: 3.1.20 _ hazard: ineffective sample prep.Severity: 3.Probability: 1.Risk index: 3.Implementation: bd facs sample prep user¿s guide__.Risk control:_afap_____.Mitigation(s) sufficient: yes or no.Root cause: based on the investigation result and the fse¿s report the root cause was a disconnected sheath tank conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for carryover.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is limited, s2, and there was no impact to the patient health or safety.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: SEE H10
• 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: 13686839
• MDR Text Key: 287552536
• Report Number: 2916837-2022-00051
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• 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: 03/21/2022

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: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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